Regulatory Brief

 Improving Procedures for FDA Advisory Committee Meetings


Formal title: Docket Number [2007D-0449] Draft Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings: Availability

The Food and Drug Administration, DHHS, has made available Draft Guidance for the Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings (Docket No. 2007D-0449)

Brief Description:

The Food and Drug Administration announced the availability of a draft guidance document for FDA advisory committee members and FDA staff entitled, "Voting Procedures for Advisory Committee Meetings." This draft document is intended to provide guidance on advisory committee voting procedures that can be used for the voting process when votes are taken during advisory committee meetings. It does not to define when votes should be taken.

AVMA Response:

The AVMA strongly supports the draft guidance addressing voting procedures for advisory committee meetings. The advisory committee most relevant to the AVMA is the Veterinary Medical Advisory Committee (VMAC), administered by the FDA Center for Veterinary Medicine (CVM).

The AVMA believes VMAC members need a sufficient opportunity to deliberate prior to voting. A collaborative advisory input broadens the base of information, enhances the deliberations, and improves the quality of decisions.

Background Documents:

Full AVMA Response (PDF)

View Federal Register document (PDF)

Status:

AVMA responded on January 4, 2008.