0A4F4F9BD490A749D5437F821CF06DF1
Good Clinical Practice and Human Subject Protections: Drugs
https://www.fda.gov/science-research/guidance-documents-including-information-sheets-and-notices/selected-fda-gcpclinical-trial-guidance-documents
http://leaux.net/URLS/ConvertAPI Text Files/0EB5080C8585DF1DCBD825358BB27B4E.en.txt
Examining the file media/Synopses/0EB5080C8585DF1DCBD825358BB27B4E.html:
This file was generated: 2020-07-14 04:46:54
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator drug:
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p.(None): in understanding the FDA's process for handling clinical investigations that include children as subjects and that have been referred
p.(None): to FDA for review under 21 CFR 50.54.
p.(None):
p.(None): Data Monitoring Committees, Establishment and Operation of Clinical Trial, Guidance for Clinical Trial Sponsors
p.(None):
p.(None): This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for
p.(None): study monitoring, and how such committees should operate.
p.(None):
p.(None): Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials, Guidance for Institutional Review Boards,
p.(None): Clinical Investigators, and Sponsors
p.(None):
p.(None): This guidance describes FDA’s longstanding policy that already-accrued data, relating to individual who cease participating in a
p.(None): study, are to be maintained as part of the study data. This pertains to data from individuals who decide to discontinue participation
p.(None): in a study, who are withdrawn by their legally authorized representative, as applicable, or who are discontinued from participation by
p.(None): the clinical investigator.
p.(None):
p.(None): Exception from Informed Consent Requirements for Emergency Research, Guidance for Institutional Review Boards,
p.(None): Clinical Investigators, and Sponsors
p.(None):
p.(None): This guidance is intended to assist Institutional Review Boards (IRBs), clinical investigators and sponsors in the development,
p.(None): conduct, and oversight of investigations to determine the safety and effectiveness of FDA regulated products (e.g., drugs, including
p.(None): biological drug products, devices) in emergency settings when an exception from the informed consent requirements is requested
p.(None): under Title 21, Code of Federal Regulations, Section 50.24 (21 CFR 50.24).
p.(None):
p.(None): Financial Disclosure by Clinical Investigators, Guidance for Clinical Investigators, Industry and FDA Staff
p.(None): This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations
p.(None): governing financial disclosure by clinical investigators, 21 CFR part 54.
p.(None):
p.(None): Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection
p.(None):
p.(None): This guidance document, developed at the department (DHHS) level, applies to all human subject research conducted or supported
p.(None): by HHS agencies or regulated by the Food and Drug Administration.
p.(None):
p.(None): Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations(October 2018)
p.(None):
p.(None): This guidance clarifies that certain provisions of the 2018 Requirements related to informed consent are not inconsistent with FDA’s
p.(None): current policies and guidances. The guidance also reminds stakeholders that FDA’s current regulations for expedited review and
p.(None): continuing review must be followed for FDA-regulated studies.
p.(None):
p.(None): Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted
p.(None): Without an IND, Guidance for Clinical Investigators, Sponsors, and IRBs
p.(None):
p.(None): This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in
p.(None): determining whether research studies involving human subjects must be conducted under an investigational new drug application
p.(None): (IND), as described in title 21 of the Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations). This guidance
p.(None): describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA’s
p.(None): experience, have been the source of confusion or misperceptions about the application of the IND regulations. This guidance
p.(None): addresses only whether an IND is needed. If your study also involves the use of a device, you should determine whether such use
p.(None): is subject to 21 CFR part 812 (the IDE regulations).
p.(None):
p.(None): Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects, Guidance for Industry
p.(None):
p.(None): This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological
p.(None): product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). It is intended to clarify for
p.(None): investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which
p.(None): some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights,
p.(None): safety, and welfare of study subjects.
p.(None):
p.(None): The Meaning of "Spouse" and "Family" in FDA’s Regulations after the Supreme Court’s Ruling in United States v. Windsor
p.(None): —Questions and Answers: Guidance for Industry, Consumers, and FDA Staff
p.(None):
p.(None): On June 26, 2013, in United States v. Windsor, 133 S.Ct. 2675, the Supreme Court struck down as unconstitutional section 3 of the
p.(None): Defense of Marriage Act (DOMA). Using a question and answer format, this guidance document informs the public of FDA’s current
p.(None): thinking about the meaning of “spouse” or “family” in our regulations in light of this ruling.
p.(None):
p.(None): Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring, Guidance for Industry
p.(None):
p.(None): This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational
p.(None): studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The
p.(None): overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor
p.(None): oversight on the most important aspects of study conduct and reporting. The guidance describes strategies for monitoring activities
p.(None): that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring
p.(None): activities to oversee a study effectively. For example, the guidance specifically encourages greater use of centralized monitoring
p.(None): methods where appropriate.
p.(None):
p.(None): Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
p.(None):
p.(None): This guidance describes how FDA reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO)
p.(None): instruments used to support claims in approved medical product labeling. A PRO instrument (i.e., a questionnaire plus the
p.(None): information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in
p.(None): medical product clinical trials. This guidance does not address the use of PRO instruments for purposes beyond evaluation of
p.(None): claims made about a medical product in labeling nor disease-specific issues.
p.(None):
p.(None): Pharmacogenomic Data Submissions, Guidance for Industry
p.(None):
p.(None): The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications
p.(None): (NDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug
p.(None): development process, the format of submissions, and how the data will be used in regulatory decision making. The guidance is
p.(None): intended to facilitate scientific progress in the area of pharmacogenomics.
p.(None): Race and Ethnicity Data in Clinical Trials, Collection of, Guidance for Industry
p.(None):
p.(None): This guidance recommends using a standardized approach for collecting and reporting race and ethnicity information in clinical trials
p.(None): conducted in the United States and abroad for certain FDA regulated products. The recommended standardized approach was
p.(None): developed by the Office of Management and Budget (OMB). The guidance lists the OMB categories for race and ethnicity and
p.(None): describes FDA's reasons for recommending the use of these categories. In addition, this guidance recommends a format for race
p.(None): and ethnicity data within study data that are submitted in standardized data sets such as the Study Data Tabulation Model or in the
p.(None): electronic Common Technical Document (eCTD).
p.(None):
p.(None): Institutional Review Boards (IRBs) and Informed Consent
p.(None): Adverse Event Reporting to IRBs- Improving Human Subject Protection, Guidance for Clinical Investigators, Sponsors,
p.(None): and IRBs
p.(None):
...
p.(None): assure the protection of the rights and welfare of human subjects enrolled in clinical investigations. This guidance should also help
p.(None): clinical investigators and sponsors better understand their responsibilities related to continuing review.
p.(None):
p.(None): IRB Registration, Frequently Asked Questions, Guidance for Institutional Review Boards (IRBs)
p.(None):
p.(None): This guidance is intended to assist IRBs in complying with the requirement for IRB registration under amended 21 CFR 56.106,
p.(None): effective July 14, 2009. Registration is accomplished through a modified version of the Internet-based registration system used by
p.(None): OHRP for registration of IRBs that are designated by institutions under FWAs. This guidance document addresses basic
p.(None): information, such as why FDA issued a new rule requiring registration, which IRBs are subject to the regulation, the type of
p.(None): information to be provided when registering, and implications of non-compliance.
p.(None):
p.(None): IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination
p.(None): of Whether an IND/IDE is Needed, Guidance for IRBs, Clinical Investigators, and Sponsors
p.(None):
p.(None): All of the parties who conduct or have oversight responsibilities for biomedical research—sponsors, clinical investigators, and
p.(None): institutional review boards (IRBs)—have responsibility for ensuring that the research complies with applicable laws and regulations
p.(None): and that risks to subjects are minimized. Although selection of clinical investigators and research sites, and determining if an
p.(None): investigational new drug application (IND) or investigational device exemption (IDE) is required are viewed primarily as sponsor
p.(None): responsibilities, FDA is issuing this guidance to clarify IRBs' responsibilities related to these activities and to encourage all parties to
p.(None): work together in order to protect the rights and welfare of study subjects.
p.(None):
p.(None): IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human
p.(None): Subjects, Guidance for Sponsors, Investigators, and Institutional Review Boards
p.(None):
p.(None): This document provides guidance to sponsors, investigators, and institutional review boards (IRBs) on enforcement of FDA
p.(None): regulations governing informed consent requirements for clinical investigations that involve no more than minimal risk to human
p.(None): subjects.
p.(None):
p.(None): Minutes of Institutional Review Board (IRB) Meetings, Guidance for Institutions and IRBs
p.(None):
p.(None): This guidance is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings. The
p.(None): guidance document describes requirements for minutes and provides recommendations for meeting the regulatory requirements for
p.(None): minutes.
p.(None):
p.(None): The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application - Guidance
p.(None): for Industry and Researchers
p.(None):
p.(None): This guidance is intended to provide information for those using radioactive drugs for certain research purposes to help determine
p.(None): whether research studies can be conducted under 21 CFR 361.1, Prescription Drugs for Human Use Generally Recognized as Safe
p.(None): and Effective and Not Misbranded: Drugs Used in Research, or whether research studies must be conducted under 21 CFR part
p.(None): 312, Investigational New Drug Application (IND).
p.(None):
p.(None): Drugs and Biologics
p.(None): Bioavailability and Bioequivalence Testing Samples, Handling and Retention of, Guidance for Industry
p.(None):
p.(None): Inspection of clinical and analytical sites that perform bioavailability (BA) and bioequivalence (BE) studies frequently reveals the
p.(None): absence of reserve samples at the testing facilities where the studies are conducted. The guidance is intended to clarify how to
p.(None): distribute test articles and reference standards to testing facilities, how to randomly select reserve samples, and how to retain
p.(None): reserve samples.
p.(None):
p.(None): Clinical Holds Following Clinical Investigator Misconduct, Guidance for Industry and Clinical Investigators on the Use of
p.(None):
p.(None): This guidance for industry and clinical investigators provides information on one use by FDA of its authority to impose a clinical hold
p.(None): on a study or study site if FDA finds that human subjects are or would be exposed to unreasonable and significant risk of illness or
p.(None): injury. Specifically, this guidance describes circumstances in which FDA may impose a clinical hold based on credible evidence that
p.(None): a clinical investigator conducting the study has committed serious violations of FDA regulations on clinical trials of human drugs and
p.(None): biologics.
p.(None):
p.(None): Exploratory IND Studies, Guidance for Industry
p.(None):
p.(None): This guidance describes the preclinical and clinical issues as well as chemistry, manufacturing and controls information that should
p.(None): be considered when planning exploratory studies including studies of related drugs or biologics under an investigational new drug
p.(None): (IND) application.
p.(None):
p.(None): FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions, Guidance for
p.(None): Industry and FDA Staff
p.(None):
p.(None): This guidance document is intended to clarify for sponsors and applicants how they can demonstrate compliance with the
p.(None): requirements of 21 CFR 312.120. It provides recommendations for the submission of information, whether in an IND or application
p.(None): for marketing approval for a drug or biological drug product, to demonstrate that a non-IND foreign clinical study was conducted in
p.(None): accordance with GCP.
p.(None):
p.(None): Food-Effect Bioavailability and Fed Bioequivalence Studies, Guidance for Industry
p.(None):
p.(None): This guidance provides recommendations to sponsors and/or applicants planning to conduct food-effect bioavailability (BA) and fed
p.(None): bioequivalence (BE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug
p.(None): applications (NDAs) and abbreviated new drug applications (ANDAs), and supplemental applications.
p.(None):
p.(None): Gender Differences in the Clinical Evaluation of Drugs, Guideline for the Study and Evaluation of, Guidance for Industry
p.(None):
p.(None): This guideline presents guidance on FDA's expectations regarding inclusion of both genders in drug development.
p.(None):
p.(None): Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, Guidance for Industry
p.(None):
p.(None): This guidance is intended to assist industry with risk management activities for drug products, including biological drug products, in
p.(None): the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
p.(None):
p.(None): IND Exemptions for Studies of Lawfully Marketed Drug or Biologicial Products for the Treatment of Cancer, Guidance for
p.(None): Industry
p.(None):
p.(None): This guidance is intended to assist sponsors in deciding whether a study of marketed drugs or biological products for treating
p.(None): cancer falls within the exemption under § 312.2(b)(1) (21 CFR 312.2(b)(1)) from the general requirement to submit an
p.(None): investigational new drug application (IND).
p.(None):
p.(None): Premarketing Risk Assessment, Guidance for Industry
p.(None):
p.(None): This guidance is intended to assist industry with risk management activities for drug products, including biological drug products, in
p.(None): the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
p.(None):
p.(None): Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related
p.(None): Submissions Using the eCTD Specifications, Guidance for Industry
p.(None):
p.(None): This guidance discusses issues related to the electronic submission of new drug applications (NDAs), abbreviated new drug
p.(None): applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), master files, advertising
p.(None): material, and promotional labeling using the electronic common technical document (eCTD) specifications.
p.(None):
p.(None): Safety Reporting Requirements for INDs and BA/BE Studies, Guidance for Industry and Investigators
p.(None):
p.(None): This guidance is intended to help sponsors and investigators comply with the requirements for investigational new drug (IND) safety
p.(None): reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies under 21 CFR 312.32, 312.64(b), and
p.(None): 320.31(d)(3). This document provides guidance to sponsors and investigators on expedited safety reporting requirements for
p.(None): human drug and biological products that are being investigated under an IND and for drugs that are the subjects of BA and BE
p.(None): studies that are exempt from the IND requirements. This guidance defines terms used for safety reporting, makes recommendations
p.(None): on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors
p.(None): and investigators.
p.(None):
p.(None): Safety Reporting Requirements for INDs and BA/BE Studies-Small Entity Compliance Guide, for Industry and Investigators
p.(None):
p.(None): This guidance is intended to help small businesses understand and comply with FDA’s safety reporting regulations for human drug
p.(None): and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the
p.(None): subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. The FDA has prepared
p.(None): this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
p.(None):
p.(None): Medical Devices
p.(None): Analyte Specific Reagents (ASRs): Frequently Asked Questions, Guidance for Industry and FDA Staff – Commercially
p.(None): Distributed
p.(None):
p.(None): This guidance document is intended to clarify the regulations regarding commercially distributed analyte specific reagents (ASRs)
p.(None): (21 CFR 809.10(e), 809.30, and 864.4020), and the role and responsibilities of ASR manufacturers. This document is not intended
p.(None): to provide guidance on the role of clinical laboratories in the development of laboratory developed tests (LDTs). The guidance
p.(None): follows the substance, spirit, and meaning of the ASR regulations already in place.
p.(None):
p.(None): Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
p.(None):
p.(None): The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of
p.(None): age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve
p.(None): the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and
p.(None): ethnic groups.
p.(None):
p.(None): Humanitarian Device Exemption (HDE) Program
p.(None): This guidance provides updated information to medical device manufacturers and healthcare systems about HDE application
p.(None): approval, and other considerations specific to the HDE Program. This guidance also reflects recent amendments made by the 21st
p.(None): Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA).
p.(None):
p.(None): Humanitarian Use Device (HUD) Designations, Guidance for Industry and Food and Drug Administration Staff
p.(None):
p.(None): This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD)
p.(None): designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development
p.(None): (OOPD). It is also designed to assist FDA reviewers in their evaluation and analysis of HUD designation requests ("HUD requests"
p.(None): or "requests").
p.(None):
p.(None): Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually
p.(None): Identifiable, Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
p.(None):
p.(None): This guidance informs sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to
p.(None): exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for
p.(None): informed consent when human specimens are used for FDA regulated in vitro diagnostic device investigations.
p.(None):
p.(None): In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions, Guidance for Industry and FDA Staff
p.(None):
p.(None): This guidance document outlines FDA regulations applicable to studies for investigational IVD devices, including those regulations
p.(None): related to human subject protection. The guidance also explains data considerations that ultimately will affect the quality of the
p.(None): premarket submission. It includes a glossary, a reference list with related web addresses, and a quick-reference table.
p.(None):
p.(None): Software Validation, General Principles of, Guidance for Industry and FDA Staff
p.(None):
p.(None): The primary purpose of this guidance is to outline general validation principles that the FDA considers applicable to the validation of
p.(None): medical device software or the validation of software used to design, develop, or manufacture medical devices. In addition, it
p.(None): contains useful validation principles applicable to software used in the conduct of clinical trials.
p.(None):
p.(None): Manufacturing Requirements for Investigational Products
p.(None): Current Good Manufacturing Practice for Phase 1 Investigational Drugs
p.(None):
p.(None): This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of
p.(None): the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1
p.(None): clinical trials. These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c)
p.(None): (referred to as phase 1 investigational drugs).
p.(None):
p.(None): Design Control Guidance for Medical Device Manufacturers
p.(None):
p.(None): This guidance is intended to assist manufacturers in understanding quality system requirements concerning design controls.
p.(None): Assistance is provided by interpreting the language of the quality systems requirements and explaining the underlying concepts in
p.(None): practical terms. As discussed under Device Advice, devices approved under an investigational device exemption (IDE) are exempt
p.(None): from the Quality System (QS) regulation, except for the design control requirements under §820.30. However, the sponsor may
p.(None): state an intention to comply with other parts of the QS regulation. The extent to which the Quality System regulation will be followed
p.(None): in manufacturing the device must be documented in the sponsor’s IDE records [§812.140(b)(4)(v)].
p.(None):
p.(None): INDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls Information
p.(None):
p.(None): This guidance provides recommendations to sponsors of investigational new drug applications (INDs) on the chemistry,
p.(None): manufacturing, and controls (CMC) information that would be submitted for phase 2 and phase 3 studies conducted under INDs.
p.(None): This document applies to human drugs (as defined in the Federal Food, Drug, and Cosmetic Act). It does not apply to botanical
p.(None): drug products, protein drug products derived from natural sources or produced by the use of biotechnology, or other biologics. The
p.(None): goals of this document are to (1) ensure that sufficient data will be submitted to the Agency to assess the safety, as well as the
p.(None): quality of the proposed clinical studies from the CMC perspective, (2) expedite the entry of new drug products into the marketplace
p.(None): by clarifying the type, extent, and reporting of CMC information for phase 2 and phase 3 studies, and (3) facilitate drug discovery
p.(None): and development
p.(None):
p.(None): Electronic Data
p.(None): Computerized Systems Used in Clinical Investigations, Guidance for Industry
p.(None):
p.(None): This guidance provides recommendations to sponsors, contract research organizations, data management centers, clinical
p.(None): investigators and institutional review boards regarding the use of computerized systems in clinical investigations.
p.(None): Electronic Source Data in Clinical Investigations, Guidance for Industry
p.(None):
p.(None): This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical
p.(None): investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. This guidance is intended to
p.(None): ensure the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA
p.(None): inspection.
p.(None):
p.(None): Part 11, Electronic Records; Electronic Signatures--Scope and Application, Guidance for Industry on
p.(None):
p.(None): This guidance is intended to describe the FDA's current thinking regarding the scope and application of part 11 of Title 21 of the
p.(None): Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
p.(None):
p.(None): Use of Electronic Informed Consent Questions and Answers, Guidance for Industry
p.(None):
p.(None): This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic
p.(None): media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of
p.(None): medical products, including human drug and biological products, medical devices, and combinations thereof.
p.(None):
p.(None):
p.(None): Resources For You
p.(None): Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
p.(None):
p.(None):
p.(None): Content current as of:
p.(None): 02/18/2020
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): FDA Archive
p.(None):
p.(None): About FDA
p.(None):
p.(None): Accessibility
p.(None):
p.(None): Visitor Information
p.(None):
p.(None): Website Policies / Privacy
p.(None):
p.(None): No FEAR Act
p.(None):
p.(None): FOIA
p.(None):
p.(None): HHS.gov
p.(None):
p.(None): USA.gov
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contact FDA
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1-888-INFO-FDA (1-888-463-6332)
...
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p.(None): studies that are exempt from the IND requirements. This guidance defines terms used for safety reporting, makes recommendations
p.(None): on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors
p.(None): and investigators.
p.(None):
p.(None): Safety Reporting Requirements for INDs and BA/BE Studies-Small Entity Compliance Guide, for Industry and Investigators
p.(None):
p.(None): This guidance is intended to help small businesses understand and comply with FDA’s safety reporting regulations for human drug
p.(None): and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the
p.(None): subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. The FDA has prepared
p.(None): this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
p.(None):
p.(None): Medical Devices
p.(None): Analyte Specific Reagents (ASRs): Frequently Asked Questions, Guidance for Industry and FDA Staff – Commercially
p.(None): Distributed
p.(None):
p.(None): This guidance document is intended to clarify the regulations regarding commercially distributed analyte specific reagents (ASRs)
p.(None): (21 CFR 809.10(e), 809.30, and 864.4020), and the role and responsibilities of ASR manufacturers. This document is not intended
p.(None): to provide guidance on the role of clinical laboratories in the development of laboratory developed tests (LDTs). The guidance
p.(None): follows the substance, spirit, and meaning of the ASR regulations already in place.
p.(None):
p.(None): Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
p.(None):
p.(None): The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of
p.(None): age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve
p.(None): the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and
p.(None): ethnic groups.
p.(None):
p.(None): Humanitarian Device Exemption (HDE) Program
p.(None): This guidance provides updated information to medical device manufacturers and healthcare systems about HDE application
p.(None): approval, and other considerations specific to the HDE Program. This guidance also reflects recent amendments made by the 21st
p.(None): Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA).
p.(None):
p.(None): Humanitarian Use Device (HUD) Designations, Guidance for Industry and Food and Drug Administration Staff
p.(None):
p.(None): This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD)
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): (IND), as described in title 21 of the Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations). This guidance
p.(None): describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA’s
p.(None): experience, have been the source of confusion or misperceptions about the application of the IND regulations. This guidance
p.(None): addresses only whether an IND is needed. If your study also involves the use of a device, you should determine whether such use
p.(None): is subject to 21 CFR part 812 (the IDE regulations).
p.(None):
p.(None): Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects, Guidance for Industry
p.(None):
p.(None): This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological
p.(None): product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). It is intended to clarify for
p.(None): investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which
p.(None): some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights,
p.(None): safety, and welfare of study subjects.
p.(None):
p.(None): The Meaning of "Spouse" and "Family" in FDA’s Regulations after the Supreme Court’s Ruling in United States v. Windsor
p.(None): —Questions and Answers: Guidance for Industry, Consumers, and FDA Staff
p.(None):
p.(None): On June 26, 2013, in United States v. Windsor, 133 S.Ct. 2675, the Supreme Court struck down as unconstitutional section 3 of the
p.(None): Defense of Marriage Act (DOMA). Using a question and answer format, this guidance document informs the public of FDA’s current
p.(None): thinking about the meaning of “spouse” or “family” in our regulations in light of this ruling.
p.(None):
p.(None): Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring, Guidance for Industry
p.(None):
p.(None): This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational
p.(None): studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The
p.(None): overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor
p.(None): oversight on the most important aspects of study conduct and reporting. The guidance describes strategies for monitoring activities
p.(None): that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring
p.(None): activities to oversee a study effectively. For example, the guidance specifically encourages greater use of centralized monitoring
p.(None): methods where appropriate.
p.(None):
p.(None): Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
p.(None):
p.(None): This guidance describes how FDA reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO)
p.(None): instruments used to support claims in approved medical product labeling. A PRO instrument (i.e., a questionnaire plus the
...
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p.(None): for Industry and Researchers
p.(None):
p.(None): This guidance is intended to provide information for those using radioactive drugs for certain research purposes to help determine
p.(None): whether research studies can be conducted under 21 CFR 361.1, Prescription Drugs for Human Use Generally Recognized as Safe
p.(None): and Effective and Not Misbranded: Drugs Used in Research, or whether research studies must be conducted under 21 CFR part
p.(None): 312, Investigational New Drug Application (IND).
p.(None):
p.(None): Drugs and Biologics
p.(None): Bioavailability and Bioequivalence Testing Samples, Handling and Retention of, Guidance for Industry
p.(None):
p.(None): Inspection of clinical and analytical sites that perform bioavailability (BA) and bioequivalence (BE) studies frequently reveals the
p.(None): absence of reserve samples at the testing facilities where the studies are conducted. The guidance is intended to clarify how to
p.(None): distribute test articles and reference standards to testing facilities, how to randomly select reserve samples, and how to retain
p.(None): reserve samples.
p.(None):
p.(None): Clinical Holds Following Clinical Investigator Misconduct, Guidance for Industry and Clinical Investigators on the Use of
p.(None):
p.(None): This guidance for industry and clinical investigators provides information on one use by FDA of its authority to impose a clinical hold
p.(None): on a study or study site if FDA finds that human subjects are or would be exposed to unreasonable and significant risk of illness or
p.(None): injury. Specifically, this guidance describes circumstances in which FDA may impose a clinical hold based on credible evidence that
p.(None): a clinical investigator conducting the study has committed serious violations of FDA regulations on clinical trials of human drugs and
p.(None): biologics.
p.(None):
p.(None): Exploratory IND Studies, Guidance for Industry
p.(None):
p.(None): This guidance describes the preclinical and clinical issues as well as chemistry, manufacturing and controls information that should
p.(None): be considered when planning exploratory studies including studies of related drugs or biologics under an investigational new drug
p.(None): (IND) application.
p.(None):
p.(None): FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions, Guidance for
p.(None): Industry and FDA Staff
p.(None):
p.(None): This guidance document is intended to clarify for sponsors and applicants how they can demonstrate compliance with the
p.(None): requirements of 21 CFR 312.120. It provides recommendations for the submission of information, whether in an IND or application
p.(None): for marketing approval for a drug or biological drug product, to demonstrate that a non-IND foreign clinical study was conducted in
p.(None): accordance with GCP.
p.(None):
p.(None): Food-Effect Bioavailability and Fed Bioequivalence Studies, Guidance for Industry
p.(None):
p.(None): This guidance provides recommendations to sponsors and/or applicants planning to conduct food-effect bioavailability (BA) and fed
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p.(None): investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. This guidance is intended to
p.(None): ensure the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA
p.(None): inspection.
p.(None):
p.(None): Part 11, Electronic Records; Electronic Signatures--Scope and Application, Guidance for Industry on
p.(None):
p.(None): This guidance is intended to describe the FDA's current thinking regarding the scope and application of part 11 of Title 21 of the
p.(None): Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
p.(None):
p.(None): Use of Electronic Informed Consent Questions and Answers, Guidance for Industry
p.(None):
p.(None): This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic
p.(None): media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of
p.(None): medical products, including human drug and biological products, medical devices, and combinations thereof.
p.(None):
p.(None):
p.(None): Resources For You
p.(None): Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
p.(None):
p.(None):
p.(None): Content current as of:
p.(None): 02/18/2020
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): FDA Archive
p.(None):
p.(None): About FDA
p.(None):
p.(None): Accessibility
p.(None):
p.(None): Visitor Information
p.(None):
p.(None): Website Policies / Privacy
p.(None):
p.(None): No FEAR Act
p.(None):
p.(None): FOIA
p.(None):
p.(None): HHS.gov
p.(None):
p.(None): USA.gov
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contact FDA
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1-888-INFO-FDA (1-888-463-6332)
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p.(None): on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors
p.(None): and investigators.
p.(None):
p.(None): Safety Reporting Requirements for INDs and BA/BE Studies-Small Entity Compliance Guide, for Industry and Investigators
p.(None):
p.(None): This guidance is intended to help small businesses understand and comply with FDA’s safety reporting regulations for human drug
p.(None): and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the
p.(None): subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. The FDA has prepared
p.(None): this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
p.(None):
p.(None): Medical Devices
p.(None): Analyte Specific Reagents (ASRs): Frequently Asked Questions, Guidance for Industry and FDA Staff – Commercially
p.(None): Distributed
p.(None):
p.(None): This guidance document is intended to clarify the regulations regarding commercially distributed analyte specific reagents (ASRs)
p.(None): (21 CFR 809.10(e), 809.30, and 864.4020), and the role and responsibilities of ASR manufacturers. This document is not intended
p.(None): to provide guidance on the role of clinical laboratories in the development of laboratory developed tests (LDTs). The guidance
p.(None): follows the substance, spirit, and meaning of the ASR regulations already in place.
p.(None):
p.(None): Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
p.(None):
p.(None): The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of
p.(None): age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve
p.(None): the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and
p.(None): ethnic groups.
p.(None):
p.(None): Humanitarian Device Exemption (HDE) Program
p.(None): This guidance provides updated information to medical device manufacturers and healthcare systems about HDE application
p.(None): approval, and other considerations specific to the HDE Program. This guidance also reflects recent amendments made by the 21st
p.(None): Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA).
p.(None):
p.(None): Humanitarian Use Device (HUD) Designations, Guidance for Industry and Food and Drug Administration Staff
p.(None):
p.(None): This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD)
p.(None): designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development
p.(None): (OOPD). It is also designed to assist FDA reviewers in their evaluation and analysis of HUD designation requests ("HUD requests"
p.(None): or "requests").
p.(None):
p.(None): Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually
p.(None): Identifiable, Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
p.(None):
p.(None): This guidance informs sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to
p.(None): exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for
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p.(None):
p.(None): Guidance Documents (Including Information Sheets) and
p.(None): Notices
p.(None):
p.(None):
p.(None):
p.(None): Selected FDA GCP/Clinical Trial Guidance Documents
p.(None): Share Tweet Email
p.(None):
p.(None):
p.(None):
p.(None): Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the
p.(None): conduct of clinical trials. As with all guidance documents, they do not create or confer any rights for or on any person and do not
p.(None): operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the
p.(None): applicable statute and regulations. However, in many places throughout these documents, specific regulations are cited and the
p.(None): requirements of the regulations are reiterated. The regulations are enforceable.
p.(None):
p.(None): Guidance Documents Grouped by Topic:
p.(None):
p.(None): General
p.(None):
p.(None): Institutional Review Boards (IRBs) and Informed Consent
p.(None): Drugs and Biologics
p.(None):
p.(None): Medical Devices
p.(None):
p.(None): Manufacturing Requirements for Investigational Products
p.(None):
p.(None): Electronic Data
p.(None):
p.(None): General
p.(None): 21 CFR 50.54, Process for Handling Referrals to FDA under, Guidance for Clinical Investigators, Institutional Review
p.(None): Boards and Sponsors)
p.(None):
p.(None): This guidance is intended to assist clinical investigators, Institutional Review Boards (IRBs), sponsors, and other interested parties
p.(None): in understanding the FDA's process for handling clinical investigations that include children as subjects and that have been referred
p.(None): to FDA for review under 21 CFR 50.54.
p.(None):
p.(None): Data Monitoring Committees, Establishment and Operation of Clinical Trial, Guidance for Clinical Trial Sponsors
p.(None):
p.(None): This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for
p.(None): study monitoring, and how such committees should operate.
p.(None):
p.(None): Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials, Guidance for Institutional Review Boards,
p.(None): Clinical Investigators, and Sponsors
p.(None):
p.(None): This guidance describes FDA’s longstanding policy that already-accrued data, relating to individual who cease participating in a
p.(None): study, are to be maintained as part of the study data. This pertains to data from individuals who decide to discontinue participation
p.(None): in a study, who are withdrawn by their legally authorized representative, as applicable, or who are discontinued from participation by
p.(None): the clinical investigator.
p.(None):
p.(None): Exception from Informed Consent Requirements for Emergency Research, Guidance for Institutional Review Boards,
p.(None): Clinical Investigators, and Sponsors
p.(None):
p.(None): This guidance is intended to assist Institutional Review Boards (IRBs), clinical investigators and sponsors in the development,
p.(None): conduct, and oversight of investigations to determine the safety and effectiveness of FDA regulated products (e.g., drugs, including
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p.(None): activities to oversee a study effectively. For example, the guidance specifically encourages greater use of centralized monitoring
p.(None): methods where appropriate.
p.(None):
p.(None): Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
p.(None):
p.(None): This guidance describes how FDA reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO)
p.(None): instruments used to support claims in approved medical product labeling. A PRO instrument (i.e., a questionnaire plus the
p.(None): information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in
p.(None): medical product clinical trials. This guidance does not address the use of PRO instruments for purposes beyond evaluation of
p.(None): claims made about a medical product in labeling nor disease-specific issues.
p.(None):
p.(None): Pharmacogenomic Data Submissions, Guidance for Industry
p.(None):
p.(None): The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications
p.(None): (NDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug
p.(None): development process, the format of submissions, and how the data will be used in regulatory decision making. The guidance is
p.(None): intended to facilitate scientific progress in the area of pharmacogenomics.
p.(None): Race and Ethnicity Data in Clinical Trials, Collection of, Guidance for Industry
p.(None):
p.(None): This guidance recommends using a standardized approach for collecting and reporting race and ethnicity information in clinical trials
p.(None): conducted in the United States and abroad for certain FDA regulated products. The recommended standardized approach was
p.(None): developed by the Office of Management and Budget (OMB). The guidance lists the OMB categories for race and ethnicity and
p.(None): describes FDA's reasons for recommending the use of these categories. In addition, this guidance recommends a format for race
p.(None): and ethnicity data within study data that are submitted in standardized data sets such as the Study Data Tabulation Model or in the
p.(None): electronic Common Technical Document (eCTD).
p.(None):
p.(None): Institutional Review Boards (IRBs) and Informed Consent
p.(None): Adverse Event Reporting to IRBs- Improving Human Subject Protection, Guidance for Clinical Investigators, Sponsors,
p.(None): and IRBs
p.(None):
p.(None): This guidance is intended to provide assistance to the research community in interpreting requirements for submitting reports of
p.(None): unanticipated problems, including certain adverse events reports, to the IRB.
p.(None):
p.(None): Centralized IRB Process in Multi center Clinical Trials, Guidance for Industry on Using a
p.(None):
p.(None): This guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in
p.(None): multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review
p.(None): process (use of a single central IRB), especially in situations where centralized review could improve efficiency of IRB review.
p.(None):
p.(None): Considerations When Transferring Clinical Investigation Oversight to Another IRB, Guidance for IRBs, Clinical
p.(None): Investigators, and Sponsors
p.(None):
p.(None): This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors
p.(None): when oversight of a previously approved, ongoing clinical investigation under FDA’s jurisdiction is transferred from one IRB to
p.(None): another IRB. This guidance also addresses questions that have been previously raised concerning procedures and processes that
...
p.(None): and investigators.
p.(None):
p.(None): Safety Reporting Requirements for INDs and BA/BE Studies-Small Entity Compliance Guide, for Industry and Investigators
p.(None):
p.(None): This guidance is intended to help small businesses understand and comply with FDA’s safety reporting regulations for human drug
p.(None): and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the
p.(None): subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. The FDA has prepared
p.(None): this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
p.(None):
p.(None): Medical Devices
p.(None): Analyte Specific Reagents (ASRs): Frequently Asked Questions, Guidance for Industry and FDA Staff – Commercially
p.(None): Distributed
p.(None):
p.(None): This guidance document is intended to clarify the regulations regarding commercially distributed analyte specific reagents (ASRs)
p.(None): (21 CFR 809.10(e), 809.30, and 864.4020), and the role and responsibilities of ASR manufacturers. This document is not intended
p.(None): to provide guidance on the role of clinical laboratories in the development of laboratory developed tests (LDTs). The guidance
p.(None): follows the substance, spirit, and meaning of the ASR regulations already in place.
p.(None):
p.(None): Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
p.(None):
p.(None): The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of
p.(None): age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve
p.(None): the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and
p.(None): ethnic groups.
p.(None):
p.(None): Humanitarian Device Exemption (HDE) Program
p.(None): This guidance provides updated information to medical device manufacturers and healthcare systems about HDE application
p.(None): approval, and other considerations specific to the HDE Program. This guidance also reflects recent amendments made by the 21st
p.(None): Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA).
p.(None):
p.(None): Humanitarian Use Device (HUD) Designations, Guidance for Industry and Food and Drug Administration Staff
p.(None):
p.(None): This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD)
p.(None): designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development
p.(None): (OOPD). It is also designed to assist FDA reviewers in their evaluation and analysis of HUD designation requests ("HUD requests"
p.(None): or "requests").
p.(None):
p.(None): Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually
p.(None): Identifiable, Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
p.(None):
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p.(None): related to human subject protection. The guidance also explains data considerations that ultimately will affect the quality of the
p.(None): premarket submission. It includes a glossary, a reference list with related web addresses, and a quick-reference table.
p.(None):
p.(None): Software Validation, General Principles of, Guidance for Industry and FDA Staff
p.(None):
p.(None): The primary purpose of this guidance is to outline general validation principles that the FDA considers applicable to the validation of
p.(None): medical device software or the validation of software used to design, develop, or manufacture medical devices. In addition, it
p.(None): contains useful validation principles applicable to software used in the conduct of clinical trials.
p.(None):
p.(None): Manufacturing Requirements for Investigational Products
p.(None): Current Good Manufacturing Practice for Phase 1 Investigational Drugs
p.(None):
p.(None): This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of
p.(None): the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1
p.(None): clinical trials. These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c)
p.(None): (referred to as phase 1 investigational drugs).
p.(None):
p.(None): Design Control Guidance for Medical Device Manufacturers
p.(None):
p.(None): This guidance is intended to assist manufacturers in understanding quality system requirements concerning design controls.
p.(None): Assistance is provided by interpreting the language of the quality systems requirements and explaining the underlying concepts in
p.(None): practical terms. As discussed under Device Advice, devices approved under an investigational device exemption (IDE) are exempt
p.(None): from the Quality System (QS) regulation, except for the design control requirements under §820.30. However, the sponsor may
p.(None): state an intention to comply with other parts of the QS regulation. The extent to which the Quality System regulation will be followed
p.(None): in manufacturing the device must be documented in the sponsor’s IDE records [§812.140(b)(4)(v)].
p.(None):
p.(None): INDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls Information
p.(None):
p.(None): This guidance provides recommendations to sponsors of investigational new drug applications (INDs) on the chemistry,
p.(None): manufacturing, and controls (CMC) information that would be submitted for phase 2 and phase 3 studies conducted under INDs.
p.(None): This document applies to human drugs (as defined in the Federal Food, Drug, and Cosmetic Act). It does not apply to botanical
p.(None): drug products, protein drug products derived from natural sources or produced by the use of biotechnology, or other biologics. The
p.(None): goals of this document are to (1) ensure that sufficient data will be submitted to the Agency to assess the safety, as well as the
p.(None): quality of the proposed clinical studies from the CMC perspective, (2) expedite the entry of new drug products into the marketplace
...
Social / Marital Status
Searching for indicator single:
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p.(None): conducted in the United States and abroad for certain FDA regulated products. The recommended standardized approach was
p.(None): developed by the Office of Management and Budget (OMB). The guidance lists the OMB categories for race and ethnicity and
p.(None): describes FDA's reasons for recommending the use of these categories. In addition, this guidance recommends a format for race
p.(None): and ethnicity data within study data that are submitted in standardized data sets such as the Study Data Tabulation Model or in the
p.(None): electronic Common Technical Document (eCTD).
p.(None):
p.(None): Institutional Review Boards (IRBs) and Informed Consent
p.(None): Adverse Event Reporting to IRBs- Improving Human Subject Protection, Guidance for Clinical Investigators, Sponsors,
p.(None): and IRBs
p.(None):
p.(None): This guidance is intended to provide assistance to the research community in interpreting requirements for submitting reports of
p.(None): unanticipated problems, including certain adverse events reports, to the IRB.
p.(None):
p.(None): Centralized IRB Process in Multi center Clinical Trials, Guidance for Industry on Using a
p.(None):
p.(None): This guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in
p.(None): multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review
p.(None): process (use of a single central IRB), especially in situations where centralized review could improve efficiency of IRB review.
p.(None):
p.(None): Considerations When Transferring Clinical Investigation Oversight to Another IRB, Guidance for IRBs, Clinical
p.(None): Investigators, and Sponsors
p.(None):
p.(None): This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors
p.(None): when oversight of a previously approved, ongoing clinical investigation under FDA’s jurisdiction is transferred from one IRB to
p.(None): another IRB. This guidance also addresses questions that have been previously raised concerning procedures and processes that
p.(None): are required and/or recommended by FDA when such oversight is transferred.
p.(None):
p.(None): HIPAA Authorizations Under FDA Regulations, IRB Review of Stand-Alone, Guidance for Industry
p.(None):
p.(None): This guidance provides clarification for IRBs of their responsibilities for reviewing and approving stand-alone authorizations under
p.(None): the HIPAA Privacy Rule.
p.(None):
p.(None): Informed Consent Elements, 21 CFR 50.25(c), Questions and Answers on, Guidance for Sponsors, Investigators and
p.(None): Institutional Review Boards
p.(None):
p.(None): This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand the new informed
p.(None): consent requirement set forth in 21 CFR 50.25(c). The guidance will assist those involved in applicable FDA-regulated clinical trials
p.(None): better understand the new informed consent requirement, including small businesses.
p.(None):
p.(None): Institutional Review Board (IRB) Written Procedures, Guidance for Institutions and IRBs
p.(None):
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p.(None): activities to oversee a study effectively. For example, the guidance specifically encourages greater use of centralized monitoring
p.(None): methods where appropriate.
p.(None):
p.(None): Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
p.(None):
p.(None): This guidance describes how FDA reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO)
p.(None): instruments used to support claims in approved medical product labeling. A PRO instrument (i.e., a questionnaire plus the
p.(None): information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in
p.(None): medical product clinical trials. This guidance does not address the use of PRO instruments for purposes beyond evaluation of
p.(None): claims made about a medical product in labeling nor disease-specific issues.
p.(None):
p.(None): Pharmacogenomic Data Submissions, Guidance for Industry
p.(None):
p.(None): The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications
p.(None): (NDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug
p.(None): development process, the format of submissions, and how the data will be used in regulatory decision making. The guidance is
p.(None): intended to facilitate scientific progress in the area of pharmacogenomics.
p.(None): Race and Ethnicity Data in Clinical Trials, Collection of, Guidance for Industry
p.(None):
p.(None): This guidance recommends using a standardized approach for collecting and reporting race and ethnicity information in clinical trials
p.(None): conducted in the United States and abroad for certain FDA regulated products. The recommended standardized approach was
p.(None): developed by the Office of Management and Budget (OMB). The guidance lists the OMB categories for race and ethnicity and
p.(None): describes FDA's reasons for recommending the use of these categories. In addition, this guidance recommends a format for race
p.(None): and ethnicity data within study data that are submitted in standardized data sets such as the Study Data Tabulation Model or in the
p.(None): electronic Common Technical Document (eCTD).
p.(None):
p.(None): Institutional Review Boards (IRBs) and Informed Consent
p.(None): Adverse Event Reporting to IRBs- Improving Human Subject Protection, Guidance for Clinical Investigators, Sponsors,
p.(None): and IRBs
p.(None):
p.(None): This guidance is intended to provide assistance to the research community in interpreting requirements for submitting reports of
p.(None): unanticipated problems, including certain adverse events reports, to the IRB.
p.(None):
p.(None): Centralized IRB Process in Multi center Clinical Trials, Guidance for Industry on Using a
p.(None):
p.(None): This guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in
p.(None): multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review
p.(None): process (use of a single central IRB), especially in situations where centralized review could improve efficiency of IRB review.
p.(None):
p.(None): Considerations When Transferring Clinical Investigation Oversight to Another IRB, Guidance for IRBs, Clinical
p.(None): Investigators, and Sponsors
p.(None):
p.(None): This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors
p.(None): when oversight of a previously approved, ongoing clinical investigation under FDA’s jurisdiction is transferred from one IRB to
...
p.(None): on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors
p.(None): and investigators.
p.(None):
p.(None): Safety Reporting Requirements for INDs and BA/BE Studies-Small Entity Compliance Guide, for Industry and Investigators
p.(None):
p.(None): This guidance is intended to help small businesses understand and comply with FDA’s safety reporting regulations for human drug
p.(None): and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the
p.(None): subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. The FDA has prepared
p.(None): this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
p.(None):
p.(None): Medical Devices
p.(None): Analyte Specific Reagents (ASRs): Frequently Asked Questions, Guidance for Industry and FDA Staff – Commercially
p.(None): Distributed
p.(None):
p.(None): This guidance document is intended to clarify the regulations regarding commercially distributed analyte specific reagents (ASRs)
p.(None): (21 CFR 809.10(e), 809.30, and 864.4020), and the role and responsibilities of ASR manufacturers. This document is not intended
p.(None): to provide guidance on the role of clinical laboratories in the development of laboratory developed tests (LDTs). The guidance
p.(None): follows the substance, spirit, and meaning of the ASR regulations already in place.
p.(None):
p.(None): Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
p.(None):
p.(None): The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of
p.(None): age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve
p.(None): the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and
p.(None): ethnic groups.
p.(None):
p.(None): Humanitarian Device Exemption (HDE) Program
p.(None): This guidance provides updated information to medical device manufacturers and healthcare systems about HDE application
p.(None): approval, and other considerations specific to the HDE Program. This guidance also reflects recent amendments made by the 21st
p.(None): Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA).
p.(None):
p.(None): Humanitarian Use Device (HUD) Designations, Guidance for Industry and Food and Drug Administration Staff
p.(None):
p.(None): This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD)
p.(None): designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development
p.(None): (OOPD). It is also designed to assist FDA reviewers in their evaluation and analysis of HUD designation requests ("HUD requests"
p.(None): or "requests").
p.(None):
p.(None): Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually
...
Searching for indicator racial:
(return to top)
p.(None):
p.(None): Medical Devices
p.(None): Analyte Specific Reagents (ASRs): Frequently Asked Questions, Guidance for Industry and FDA Staff – Commercially
p.(None): Distributed
p.(None):
p.(None): This guidance document is intended to clarify the regulations regarding commercially distributed analyte specific reagents (ASRs)
p.(None): (21 CFR 809.10(e), 809.30, and 864.4020), and the role and responsibilities of ASR manufacturers. This document is not intended
p.(None): to provide guidance on the role of clinical laboratories in the development of laboratory developed tests (LDTs). The guidance
p.(None): follows the substance, spirit, and meaning of the ASR regulations already in place.
p.(None):
p.(None): Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
p.(None):
p.(None): The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of
p.(None): age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve
p.(None): the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and
p.(None): ethnic groups.
p.(None):
p.(None): Humanitarian Device Exemption (HDE) Program
p.(None): This guidance provides updated information to medical device manufacturers and healthcare systems about HDE application
p.(None): approval, and other considerations specific to the HDE Program. This guidance also reflects recent amendments made by the 21st
p.(None): Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA).
p.(None):
p.(None): Humanitarian Use Device (HUD) Designations, Guidance for Industry and Food and Drug Administration Staff
p.(None):
p.(None): This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD)
p.(None): designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development
p.(None): (OOPD). It is also designed to assist FDA reviewers in their evaluation and analysis of HUD designation requests ("HUD requests"
p.(None): or "requests").
p.(None):
p.(None): Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually
p.(None): Identifiable, Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
p.(None):
p.(None): This guidance informs sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to
p.(None): exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for
p.(None): informed consent when human specimens are used for FDA regulated in vitro diagnostic device investigations.
...
Social / employees
Searching for indicator employees:
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p.(None): Without an IND, Guidance for Clinical Investigators, Sponsors, and IRBs
p.(None):
p.(None): This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in
p.(None): determining whether research studies involving human subjects must be conducted under an investigational new drug application
p.(None): (IND), as described in title 21 of the Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations). This guidance
p.(None): describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA’s
p.(None): experience, have been the source of confusion or misperceptions about the application of the IND regulations. This guidance
p.(None): addresses only whether an IND is needed. If your study also involves the use of a device, you should determine whether such use
p.(None): is subject to 21 CFR part 812 (the IDE regulations).
p.(None):
p.(None): Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects, Guidance for Industry
p.(None):
p.(None): This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological
p.(None): product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). It is intended to clarify for
p.(None): investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which
p.(None): some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights,
p.(None): safety, and welfare of study subjects.
p.(None):
p.(None): The Meaning of "Spouse" and "Family" in FDA’s Regulations after the Supreme Court’s Ruling in United States v. Windsor
p.(None): —Questions and Answers: Guidance for Industry, Consumers, and FDA Staff
p.(None):
p.(None): On June 26, 2013, in United States v. Windsor, 133 S.Ct. 2675, the Supreme Court struck down as unconstitutional section 3 of the
p.(None): Defense of Marriage Act (DOMA). Using a question and answer format, this guidance document informs the public of FDA’s current
p.(None): thinking about the meaning of “spouse” or “family” in our regulations in light of this ruling.
p.(None):
p.(None): Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring, Guidance for Industry
p.(None):
p.(None): This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational
p.(None): studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The
p.(None): overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor
p.(None): oversight on the most important aspects of study conduct and reporting. The guidance describes strategies for monitoring activities
...
Social / gender
Searching for indicator gender:
(return to top)
p.(None):
p.(None): This guidance describes the preclinical and clinical issues as well as chemistry, manufacturing and controls information that should
p.(None): be considered when planning exploratory studies including studies of related drugs or biologics under an investigational new drug
p.(None): (IND) application.
p.(None):
p.(None): FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions, Guidance for
p.(None): Industry and FDA Staff
p.(None):
p.(None): This guidance document is intended to clarify for sponsors and applicants how they can demonstrate compliance with the
p.(None): requirements of 21 CFR 312.120. It provides recommendations for the submission of information, whether in an IND or application
p.(None): for marketing approval for a drug or biological drug product, to demonstrate that a non-IND foreign clinical study was conducted in
p.(None): accordance with GCP.
p.(None):
p.(None): Food-Effect Bioavailability and Fed Bioequivalence Studies, Guidance for Industry
p.(None):
p.(None): This guidance provides recommendations to sponsors and/or applicants planning to conduct food-effect bioavailability (BA) and fed
p.(None): bioequivalence (BE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug
p.(None): applications (NDAs) and abbreviated new drug applications (ANDAs), and supplemental applications.
p.(None):
p.(None): Gender Differences in the Clinical Evaluation of Drugs, Guideline for the Study and Evaluation of, Guidance for Industry
p.(None):
p.(None): This guideline presents guidance on FDA's expectations regarding inclusion of both genders in drug development.
p.(None):
p.(None): Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, Guidance for Industry
p.(None):
p.(None): This guidance is intended to assist industry with risk management activities for drug products, including biological drug products, in
p.(None): the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
p.(None):
p.(None): IND Exemptions for Studies of Lawfully Marketed Drug or Biologicial Products for the Treatment of Cancer, Guidance for
p.(None): Industry
p.(None):
p.(None): This guidance is intended to assist sponsors in deciding whether a study of marketed drugs or biological products for treating
p.(None): cancer falls within the exemption under § 312.2(b)(1) (21 CFR 312.2(b)(1)) from the general requirement to submit an
p.(None): investigational new drug application (IND).
p.(None):
p.(None): Premarketing Risk Assessment, Guidance for Industry
p.(None):
...
Social / orphan
Searching for indicator orphan:
(return to top)
p.(None):
p.(None): The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of
p.(None): age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve
p.(None): the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and
p.(None): ethnic groups.
p.(None):
p.(None): Humanitarian Device Exemption (HDE) Program
p.(None): This guidance provides updated information to medical device manufacturers and healthcare systems about HDE application
p.(None): approval, and other considerations specific to the HDE Program. This guidance also reflects recent amendments made by the 21st
p.(None): Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA).
p.(None):
p.(None): Humanitarian Use Device (HUD) Designations, Guidance for Industry and Food and Drug Administration Staff
p.(None):
p.(None): This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD)
p.(None): designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development
p.(None): (OOPD). It is also designed to assist FDA reviewers in their evaluation and analysis of HUD designation requests ("HUD requests"
p.(None): or "requests").
p.(None):
p.(None): Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually
p.(None): Identifiable, Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
p.(None):
p.(None): This guidance informs sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to
p.(None): exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for
p.(None): informed consent when human specimens are used for FDA regulated in vitro diagnostic device investigations.
p.(None):
p.(None): In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions, Guidance for Industry and FDA Staff
p.(None):
p.(None): This guidance document outlines FDA regulations applicable to studies for investigational IVD devices, including those regulations
p.(None): related to human subject protection. The guidance also explains data considerations that ultimately will affect the quality of the
p.(None): premarket submission. It includes a glossary, a reference list with related web addresses, and a quick-reference table.
p.(None):
p.(None): Software Validation, General Principles of, Guidance for Industry and FDA Staff
p.(None):
p.(None): The primary purpose of this guidance is to outline general validation principles that the FDA considers applicable to the validation of
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None):
p.(None): Medical Devices
p.(None):
p.(None): Manufacturing Requirements for Investigational Products
p.(None):
p.(None): Electronic Data
p.(None):
p.(None): General
p.(None): 21 CFR 50.54, Process for Handling Referrals to FDA under, Guidance for Clinical Investigators, Institutional Review
p.(None): Boards and Sponsors)
p.(None):
p.(None): This guidance is intended to assist clinical investigators, Institutional Review Boards (IRBs), sponsors, and other interested parties
p.(None): in understanding the FDA's process for handling clinical investigations that include children as subjects and that have been referred
p.(None): to FDA for review under 21 CFR 50.54.
p.(None):
p.(None): Data Monitoring Committees, Establishment and Operation of Clinical Trial, Guidance for Clinical Trial Sponsors
p.(None):
p.(None): This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for
p.(None): study monitoring, and how such committees should operate.
p.(None):
p.(None): Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials, Guidance for Institutional Review Boards,
p.(None): Clinical Investigators, and Sponsors
p.(None):
p.(None): This guidance describes FDA’s longstanding policy that already-accrued data, relating to individual who cease participating in a
p.(None): study, are to be maintained as part of the study data. This pertains to data from individuals who decide to discontinue participation
p.(None): in a study, who are withdrawn by their legally authorized representative, as applicable, or who are discontinued from participation by
p.(None): the clinical investigator.
p.(None):
p.(None): Exception from Informed Consent Requirements for Emergency Research, Guidance for Institutional Review Boards,
p.(None): Clinical Investigators, and Sponsors
p.(None):
p.(None): This guidance is intended to assist Institutional Review Boards (IRBs), clinical investigators and sponsors in the development,
p.(None): conduct, and oversight of investigations to determine the safety and effectiveness of FDA regulated products (e.g., drugs, including
p.(None): biological drug products, devices) in emergency settings when an exception from the informed consent requirements is requested
p.(None): under Title 21, Code of Federal Regulations, Section 50.24 (21 CFR 50.24).
p.(None):
p.(None): Financial Disclosure by Clinical Investigators, Guidance for Clinical Investigators, Industry and FDA Staff
p.(None): This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations
p.(None): governing financial disclosure by clinical investigators, 21 CFR part 54.
p.(None):
p.(None): Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection
p.(None):
p.(None): This guidance document, developed at the department (DHHS) level, applies to all human subject research conducted or supported
p.(None): by HHS agencies or regulated by the Food and Drug Administration.
p.(None):
p.(None): Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations(October 2018)
p.(None):
p.(None): This guidance clarifies that certain provisions of the 2018 Requirements related to informed consent are not inconsistent with FDA’s
p.(None): current policies and guidances. The guidance also reminds stakeholders that FDA’s current regulations for expedited review and
p.(None): continuing review must be followed for FDA-regulated studies.
p.(None):
p.(None): Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted
p.(None): Without an IND, Guidance for Clinical Investigators, Sponsors, and IRBs
p.(None):
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): guidance document describes requirements for minutes and provides recommendations for meeting the regulatory requirements for
p.(None): minutes.
p.(None):
p.(None): The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application - Guidance
p.(None): for Industry and Researchers
p.(None):
p.(None): This guidance is intended to provide information for those using radioactive drugs for certain research purposes to help determine
p.(None): whether research studies can be conducted under 21 CFR 361.1, Prescription Drugs for Human Use Generally Recognized as Safe
p.(None): and Effective and Not Misbranded: Drugs Used in Research, or whether research studies must be conducted under 21 CFR part
p.(None): 312, Investigational New Drug Application (IND).
p.(None):
p.(None): Drugs and Biologics
p.(None): Bioavailability and Bioequivalence Testing Samples, Handling and Retention of, Guidance for Industry
p.(None):
p.(None): Inspection of clinical and analytical sites that perform bioavailability (BA) and bioequivalence (BE) studies frequently reveals the
p.(None): absence of reserve samples at the testing facilities where the studies are conducted. The guidance is intended to clarify how to
p.(None): distribute test articles and reference standards to testing facilities, how to randomly select reserve samples, and how to retain
p.(None): reserve samples.
p.(None):
p.(None): Clinical Holds Following Clinical Investigator Misconduct, Guidance for Industry and Clinical Investigators on the Use of
p.(None):
p.(None): This guidance for industry and clinical investigators provides information on one use by FDA of its authority to impose a clinical hold
p.(None): on a study or study site if FDA finds that human subjects are or would be exposed to unreasonable and significant risk of illness or
p.(None): injury. Specifically, this guidance describes circumstances in which FDA may impose a clinical hold based on credible evidence that
p.(None): a clinical investigator conducting the study has committed serious violations of FDA regulations on clinical trials of human drugs and
p.(None): biologics.
p.(None):
p.(None): Exploratory IND Studies, Guidance for Industry
p.(None):
p.(None): This guidance describes the preclinical and clinical issues as well as chemistry, manufacturing and controls information that should
p.(None): be considered when planning exploratory studies including studies of related drugs or biologics under an investigational new drug
p.(None): (IND) application.
p.(None):
p.(None): FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions, Guidance for
p.(None): Industry and FDA Staff
p.(None):
p.(None): This guidance document is intended to clarify for sponsors and applicants how they can demonstrate compliance with the
p.(None): requirements of 21 CFR 312.120. It provides recommendations for the submission of information, whether in an IND or application
p.(None): for marketing approval for a drug or biological drug product, to demonstrate that a non-IND foreign clinical study was conducted in
p.(None): accordance with GCP.
p.(None):
p.(None): Food-Effect Bioavailability and Fed Bioequivalence Studies, Guidance for Industry
p.(None):
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| children | Child |
| drug | Drug Usage |
| emergency | Public Emergency |
| employees | employees |
| ethnicity | Ethnicity |
| family | Motherhood/Family |
| foia | Access to information |
| gender | gender |
| illness | Physically Disabled |
| language | Linguistic Proficiency |
| orphan | orphan |
| race | Racial Minority |
| racial | Racial Minority |
| single | Marital Status |
| substance | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| race | ['racial'] |
| racial | ['race'] |
| substance | ['drug'] |
Trigger Words
consent
developing
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input