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The Future of Drug Safety: Promoting and Protecting the Health of the Public
Timeline for Planning an Advisory Committee Meeting
Planning of an advisory committee meeting takes roughly 4 months and involves the following:
Advisory committee members must fill out a “Conflict of Interest Disclosure Report for SGEs” (form 3410) for each topic to be discussed.
FDA staff (advisory committee oversight and management) must determine whether existing advisory committee members have a conflict of interest (COI) regarding the current topic and what other expertise they need (if not already on the committee, or to replace a committee member with a COI in that topic).
Five weeks before the meeting: proposed waivers need to be submitted for approval. Waivers are reviewed by
the executive secretary
the committee management specialist
the program officer
the chief of scientific advisers and consultants staff
the ethics specialist
the director of advisory committee oversight
the senior associate commissioner.
The dockets office needs a few days to a week to prepare the posting for the Federal Register.
Fifteen days before the meeting: FDA must post notice of the advisory committee meeting, including the topic to be discussed and any waivers obtained for the meeting on its Web site (Hinchey Amendment). FDA also posts this information in the FederalRegister.
No later than the day of the meeting: if the Secretary of Health and Human Services or FDA discovers a COI less than 15 days before the advisory committee meeting, the agency must make a disclosure as soon as possible but in any event no later than the date of the meeting (Hinchey Amendment).
CDER has 17 topic-specific advisory committees,9 each composed mainly of clinical experts in a specific field, such as gastrointestinal or onco-
Number of advisory committees in other units of FDA: Center for Biologics Evaluation and Research = 5, Center for Devices and Radiological = 21, Center for Food Safety and Applied Nutrition = 1, Center for Veterinary Medicine = 1, National Center for Toxicological Research = 2, Office of the Commissioner = 2.