U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  1. Regulatory Information

Search for FDA Guidance Documents

The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.

If you cannot find the document you’re looking for here, you can browse separate collections of guidance documents by topic.

Go to Guidance Document Search

 

Guidance Document Search



Summary Document Issue Date FDA Organization Topic Guidance Status Open for Comment Comment Closing Date on Draft Docket Number Excerpt
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry: Draft Guidance for Industry PDF (208.66 KB)PDF (208.66 KB) of Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry: Draft Guidance for Industry Center for Drug Evaluation and Research Clinical - Antimicrobial Draft Yes FDA-2021-D-0519
Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry PDF (113.59 KB)PDF (113.59 KB) of Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry Office of Regulatory Affairs

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research
Investigation & Enforcement, Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC), Current Good Manufacturing Practice (CGMP) Final FDA-2018-D-2326
Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations) PDF (406.65 KB)PDF (406.65 KB) of Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations) Office of Food Additive Safety Food Contact Substances (FCS), Food & Color Additives, Contaminants, Ingredients Final FDA-2020-D-1456
CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs PDF (266.69 KB)PDF (266.69 KB) of CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs Center for Veterinary Medicine Premarket, User Fees, New Animal Drug Application (NADA), Target Animal – Effectiveness, Antimicrobial Resistance Final No FDA-2019-D-3361
FDA Oversight of Food Products Covered by Systems Recognition Arrangements PDF (214.73 KB)PDF (214.73 KB) of FDA Oversight of Food Products Covered by Systems Recognition Arrangements Office of Regulatory Affairs

Center for Food Safety and Applied Nutrition
Export, Import, Investigational Use Draft Yes FDA-2019-D-1997
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry PDF (642.88 KB)PDF (642.88 KB) of Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry Center for Tobacco Products Final FDA-2020-D-0988
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff PDF (591.94 KB)PDF (591.94 KB) of Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff Center for Devices and Radiological Health Premarket, Animal Cell-Based Products Final No FDA-2019-D-1261
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) PDF (1.17 MB)PDF (1.17 MB) of Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) Center for Tobacco Products Final FDA-2019-D-5364
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff PDF (478.28 KB)PDF (478.28 KB) of Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff Center for Biologics Evaluation and Research

Center for Devices and Radiological Health
UDI, Labeling Final FDA-2016-D-1853
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications : Draft Guidance for Industry PDF (186.49 KB)PDF (186.49 KB) of Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications : Draft Guidance for Industry Center for Drug Evaluation and Research Clinical - Medical Draft FDA-2020-D-2323

Sign up for Guidance Documents email updates

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top