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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

                                                                                  Content current as of:
      07/22/2022Search for FDA Guidance Documents

          
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