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Preparation and Submission of Advisory Committee Briefing Materials for Public Release

This guidance provides recommendations for industry sponsors, applicants, and petitioners on how to prepare and submit briefing materials for FDA advisory committee meetings, ensuring public availability of these materials in compliance with FACA requirements while protecting confidential information. It covers the process for making briefing materials publicly available and timelines for submission.

  1. Review guidance timelines and plan submission schedule accordingly (55 business days before meeting)
  2. Prepare briefing materials:
    • Include only information relevant to meeting topics
    • Avoid promotional/misleading statements
    • Submit in both paper and electronic formats
  3. For materials containing confidential information:
    • Prepare complete version marked “Not for Public Release”
    • Prepare redacted version marked “Available for Public Release”
    • Clearly identify and justify redactions
  4. For fully releasable materials:
    • Mark as “Available for Public Release”
    • Submit according to Appendix A timeline
  5. Review FDA feedback on redactions and choose appropriate response option:
    • Remove disputed information
    • Accept FDA determination
    • Submit fully releasable version
    • Seek judicial review
  6. Ensure no discussion of redacted confidential information during open portions of advisory committee meetings
  7. Monitor FDA website for posted materials and verify accuracy of public disclosures

Key Considerations

Labelling

  • Information proposed to be included in product labeling must be disclosed
  • Product labeling information like indications, usage, dosage, administration, and safety information should be publicly available

Safety

  • Summaries of clinical and non-clinical safety data must be disclosed
  • Summaries of adverse drug reaction data must be disclosed
  • Written discussion or analysis of safety data relevant to the meeting topic must be disclosed

Other considerations

  • 5 U.S.C. App. 2: Federal Advisory Committee Act (FACA)
  • 5 U.S.C. § 552: Freedom of Information Act (FOIA)

Original guidance

  • Preparation and Submission of Advisory Committee Briefing Materials for Public Release
  • HTML / PDF
  • Issue date: 2008-08-01
  • Last changed date: 2019-04-20
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Food & Color Additives, Biologics, Cosmetics, Advisory Committees
  • ReguVirta summary file ID: 801293105f88cbdf42d37cce96ca3901
This post is licensed under CC BY 4.0 by the author.