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