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FDA Guidance on Conflict of Interest for Advisory Committee Members, Consultants and Experts
Table of Contents

  1. Introduction
  2. Policies and Procedures for Handling Conflicts of Interest with FDA Advisory Committee Members, Consultants and Experts
  3. The Waiver Criteria Document
    1. General Principles
    2. Definitions
    3. The Table
      1. Stocks and Investments
      2. Primary Employment
      3. Consultant Advisor
      4. Contracts/Grants/CRADAS
      5. Patents/Royalties/Trademarks
      6. Expert Witness
      7. Teaching/Speaking/Writing
      8. Department Heads
      9. Exceptions for Institutional Directors
  4. Appendices
    1. Sample Transmittal (Cover) Memorandum
    2. Sample Checklist and Waiver - Full
    3. Sample Checklist and Waiver - General
    4. Sample Appearance Determination
    5. FDAMA Guidance to Industry (CBER/CDER)
    6. Sample FDAMA Waiver
    7. Addendum to WCD 2000
    8. Financial Disclosure Statement

February 2000

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