Cross-cutting Guidance Documents

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Guidance Documents:

• Conducting Remote Regulatory Assessments - Questions and Answers - 07/2022
• Collecting and Providing 702(b) Portions of FDA Official Samples - Questions and Answers 01/2022
• Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection - 10/2014
• Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases - 12/2017
• Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration - 12/2006
• Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology -06/2014
• Consumer-Directed Broadcast Advertisements - 08/1999
• Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products - 02/2008
• Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products - 12/2019
• Developing and Labeling In vitro Companion Diagnostic Devices for a Specifc Group or Class of Oncology Therapeutic Products - 12/2018
• Direct Final Rule Procedures - 11/1997
• Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers - 06/2018
• Part 11, Electronic Records; Electronic Signatures - Scope and Application - 08/2003
• Emergency Use Authorization of Medical Products and Related Authorities - 01/2017
• Form 3674 - Certifications to Accompany Drug, Biological Product, and Device Submissions - 06/2017
• Gifts to FDA: Evaluation and Acceptance - 12/2016
• 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 - 1/2009
• Humanitarian Use Device (HUD) Designations 01/2013
• Industry Supported Scientific and Educational Activities - 11/1997
• Material Threat Medical Countermeasure Priority Review Vouchers - 01/2018
• The Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v. Windsor - 04/2014
• Medical Product Communications That Are Consistent With the FDA-Required Labeling: Questions and Answers - 06/2018
• Meetings with the Office of Orphan Products Development - 07/2015
• Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions 02/2006
• Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry 11/2014
• Release of ORA Laboratory Analytical Results to the Responsible Party - 03/2019
• Review and Update of Device Establishment Inspection Processes and Standards - 03/2019
• Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages -03/2010
• Using Electronic Means to Distribute Certain Product Information - 03/2006