Preparation and Submission of Advisory Committee Briefing Materials for Public Release

What You Need to Know? 👇

What are the key timelines for submitting briefing materials to FDA advisory committees?

For fully releasable materials, sponsors must submit 22 business days before the meeting. For materials containing confidential information, submission is required 42 business days before. FDA posts public versions no later than 2 full business days before the meeting.

Which types of information in advisory committee briefings are typically exempt from public disclosure?

Manufacturing processes, clinical raw data, proprietary formulations not in labeling, supplier information, and personal privacy details are generally exempt. However, safety/effectiveness summaries, protocols, and proposed labeling information are typically disclosable under FOIA.

How should sponsors prepare briefing materials to minimize FDA review time?

Submit both paper and electronic versions, clearly segregate confidential information, mark materials appropriately (“Available for Public Release” or “Not for Public Release”), and include only meeting-relevant information without promotional language or speculation beyond study conclusions.

What happens if sponsors disagree with FDA’s disclosure determinations for briefing materials?

Sponsors have four options: remove disputed information, accept FDA’s determination, agree no information is exempt, or seek judicial review in federal court. If court action is taken, FDA may postpone the advisory committee meeting.

Can sponsors discuss confidential information during open advisory committee meetings?

No. Information claimed as exempt from FOIA disclosure should not be discussed during open portions of meetings. This would be inconsistent with assertions about the information’s confidential status and undermine exemption claims.

What disclaimer does FDA use when posting sponsor briefing materials on their website?

FDA posts: “The statements contained in this document are those of the product’s sponsor. FDA does not necessarily agree with the sponsor’s statements. FDA has not made a final determination about the issues described in this document.”

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What You Need to Do 👇

Recommended Actions

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

• Briefing materials must be submitted in both paper and electronic formats
• Two versions should be prepared if materials contain confidential information:
  • Complete version with confidential information marked “Not for Public Release”
  • Redacted version marked “Available for Public Release”
• Materials must be submitted according to specified timelines (55 business days before meeting)
• Only information related to meeting topics should be included
• Promotional or misleading statements must be avoided
• Confidential information like manufacturing processes, raw data, supplier names etc. can be redacted
• FDA will review and validate redactions proposed by sponsors

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Relevant Guidances 🔗

• Public Disclosure of Advisory Committee Members’ Financial Interests and Waivers
• Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
• Procedures for Medical Devices Advisory Committee Panel Meetings

Related references and norms 📂

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

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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 ID: 801293105f88cbdf42d37cce96ca3901