Guidances

Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies.

Search for FDA Guidance Documents

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

How to Provide Input for Guidance Development

Interested parties have a number of opportunities to provide input into guidance development. For more information please see Opportunities for Input Into Guidance Development (PDF - 21 KB).

Interested parties also have a number of opportunities to comment on agency rulemaking. For more information please see Comment on Proposed Regulations and Submit Petitions.

Possible Topics for Future Guidance Development

• Animal and Veterinary
  • Center for Veterinary Medicine Guidance Documents Under Development
  • Center for Devices and Radiological Health Proposed Guidance Development
  • Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2018 (PDF - 46KB)
  • Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022

  Guidance Documents By Product Area

  • All FDA Guidances
  • Combination Products
  • Animal and Veterinary
    • Recent Animal and Veterinary Guidances
    • Recent Drugs Guidances
    • Recent Food Guidances
    • Recent Radiation-Emitting Guidances
    • Recent Vaccines, Blood, Biologics Guidances

    Guidance Documents By Topic

    • General and Cross-Cutting Topics
    • Advisory Committee
    • Clinical Trials
    • Import and Export
    • International Council for Harmonisation (ICH)
    • Veterinary International Conference on Harmonization (VICH)

    Withdrawn Guidance Documents

    • Animal and Veterinary
      • Withdrawn/Replaced Guidances
      • Withdrawn Guidances
      • Withdrawn Guidance