Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft document for the public, FDA advisory committee members, and FDA staff entitled "Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees" dated March 2007. This draft guidance describes the factors and analyses that should be used in considering whether an advisory committee member has a potential conflict of interest and whether participation in a meeting is appropriate. This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA policy in applying the applicable statutory and regulatory requirements. This draft guidance, when finalized, will replace the guidance document entitled "FDA Waiver Criteria 2000."