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Regulatory Guidance List

Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

Center for Biologics Evaluation and Research

PUBLISHED
PDF Doc
02/21/2018
Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
01/14/2009
Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry

Office of Regulatory Affairs

PUBLISHED
PDF Doc
08/14/2020
Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and Food and Drug Administration Staff

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
1/24/2006
Computerized Systems Used in Clinical Investigations: Guidance for Industry

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
09/13/2007
Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
05/23/2014
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
03/29/2005
Electronic Source Data in Clinical Investigations: Guidance for Industry

Center for Biologics Evaluation and Research

PUBLISHED
PDF Doc
06/30/2016
Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
03/15/2019
Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
09/12/2017
FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions: Guidance for Industry and FDA Staff

Center for Biologics Evaluation and Research

PUBLISHED
PDF Doc
06/03/2016
Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
02/01/2013
General Principles of Software Validation: Guidance for Industry and FDA Staff

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
06/04/2010
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
03/24/2005
Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration Staff

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
09/06/2019
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer: Guidance for Industry

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
06/25/2010
Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
08/19/2004
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
09/11/2023
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry

Center for Food Safety and Applied Nutrition

PUBLISHED
PDF Doc
09/10/2013
Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
02/27/2012
Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry

Office of Regulatory Affairs

PUBLISHED
PDF Doc
08/07/2013
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
01/26/2022
Premarketing Risk Assessment: Guidance for Industry

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
03/01/2005
Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
12/20/2012
The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
10/1/2000
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff

Office of Regulatory Affairs

PUBLISHED
PDF Doc
3/16/2006
Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
07/27/2016
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff

Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Policy

PUBLISHED
PDF Doc
11/13/2020
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry

Center for Biologics Evaluation and Research

PUBLISHED
PDF Doc
10/01/2011
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
10/26/2016
Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors

Center for Food Safety and Applied Nutrition

PUBLISHED
PDF Doc
5/10/2007
Development and Use of Risk Minimization Action Plans: Guidance for Industry

Office of Regulatory Affairs

PUBLISHED
PDF Doc
07/14/2008
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
11/25/2013
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products: Guidance for Industry

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
09/18/2013
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

Center for Biologics Evaluation and Research

PUBLISHED
PDF Doc
03/28/2006
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers: Guidance for Industry

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
4/1/2013
Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry,and FDA Staff

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
03/01/2012
Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
1/1/2006
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: Guidance for Industry

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
01/11/2002
Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
04/25/2006
In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff

Center for Biologics Evaluation and Research

PUBLISHED
PDF Doc
09/05/2019
Independent Consultants for Biotechnology Clinical Trial Protocols: Guidance for Industry

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
01/15/2004
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products: Guidance for IRBs and Clinical Investigators

Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice

PUBLISHED
PDF Doc
08/15/2023
Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBs

Office of Regulatory Affairs

PUBLISHED
PDF Doc
05/17/2018
IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
10/23/2009
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for Industry

Office of Regulatory Affairs

PUBLISHED
PDF Doc
09/25/2017
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

Center for Food Safety and Applied Nutrition

PUBLISHED
PDF Doc
09/05/2003
Pharmacogenomic Data Submissions: Guidance for Industry

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
12/09/2009
Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
03/29/2005
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)

Center for Drug Evaluation and Research

PUBLISHED
PDF Doc
12/20/2012
Using a Centralized IRB Review Process in Multicenter Clinical Trials: Guidance for Industry

Center for Devices and Radiological Health

PUBLISHED
PDF Doc
9/2/2004
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