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Voting Procedures for Advisory Committee Meetings

This guidance outlines uniform procedures for voting during FDA advisory committee meetings. It provides recommendations for FDA advisory committee members and FDA staff on how to conduct voting processes effectively while ensuring transparency and integrity of the results.

  1. Establish a standardized simultaneous voting procedure for advisory committee meetings
  2. Develop clear templates for presenting voting questions without leading language
  3. Create a process for documenting and publishing voting results
  4. Implement a system for providing comprehensive briefing materials in advance
  5. Set up procedures for pre-vote discussions and post-vote explanations
  6. Create guidelines for chairs regarding the introduction of new voting questions
  7. Establish a protocol for managing the timing and flow of voting procedures
  8. Develop a process for recording and maintaining transparency of voting records
  9. Create training materials for advisory committee members on voting procedures
  10. Establish a verification process to ensure voting questions are clear and well-understood before voting begins

Key Considerations

Other considerations

  • 21 CFR Part 14: Public Hearing Before a Public Advisory Committee

Original guidance

  • Voting Procedures for Advisory Committee Meetings
  • 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: 9c6bedc97a47fe3874878a9d02d71fcb
This post is licensed under CC BY 4.0 by the author.