Regulatory Information
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FDA Guidance Documents: General and Cross-Cutting Topics
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Guidance Documents:
- 03/2001
Acceptance of Foreign Clinical Studies - 01/2009
Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 - 12/2006
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration - 06/2011
Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology - 08/1999
Consumer-Directed Broadcast Advertisements - 02/2008
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products - 11/1997
Direct Final Rule Procedures - 08/2003
Part 11, Electronic Records; Electronic Signatures — Scope and Application - 11/2002
Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records (PDF - 143KB) - 09/2001
(247) 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms; Draft Guidance for Industry (PDF - 117KB) - 09/2001
(246) 21 CFR Part 11; Electronic Records; Electronic Signatures,Validation; Draft Guidance for Industry (PDF - 202KB) - 07/2007
Emergency Use Authorization of Medical Products - 03/2003
FDA Issues Food and Cosmetic Security Preventive Measures Guidance - 05/2004
Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV - 01/2009
Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices - 11/1997
Industry Supported Scientific and Educational Activities (PDF - 428KB) - 10/2003
Providing Regulatory Submissions in Electronic Format — General Considerations - 03/2010
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages - 01/2009
Submission Of Laboratory Packages By Accredited Laboratories - 09/1997
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use - 03/2006
Using Electronic Means to Distribute Certain Product Information - 01/2009
Voluntary Third-Party Certification Programs for Foods and Feeds
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