Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees." This draft document is intended to provide guidance for industry, FDA staff (including special Government employees (SGEs), and other interested stakeholders concerning disclosure of financial interests for which FDA advisory committee SGEs have received conflict of interest waivers. This draft guidance describes a new policy of disclosing specific information concerning the financial interests that give rise to the waiver of a conflict of interest.