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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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