Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA advisory committee changes

This article was originally published in The Tan Sheet

Executive Summary

FDA releases a 1draft guidance on changes to advisory committee processes, according to a notice slated for publication in the Nov. 19 Federal Register. Among changes, advisory committee members would vote simultaneously rather than sequentially on issues before the panel to avoid influencing one another's votes, the agency says. Although FDA does not mandate any particular voting method, it suggests voting by show of hands, a simultaneous show of "yes" or "no" cards or written balloting. Changes are part of ongoing reforms to the agency's advisory committee policies based on recommendations from the Institute of Medicine and pressure from Congress. In March, FDA issued a draft guidance limiting the potentially conflicting financial interests of members (2"The Tan Sheet" March 26, 2007, p. 7)...

You may also be interested in...

NDAC Chair Gives Vote Of Confidence To Simultaneous Voting

FDA's use of "simultaneous voting" at advisory committee meetings concerning OTC issues in December allowed members to vote free of influence by other members' votes while also proceeding with few technical problems

Advisory Committees Free Of Conflicts May Be Unfeasible, FDA Review Says

FDA's policy of granting waivers for financial conflicts of interest for advisory committee members is supported by an independent review commissioned by the agency, which determined that constructing advisory committees free from conflicts of interest would be expensive and time-consuming and may be unfeasible for certain topics and fields of expertise

Draft Conflict Of Interest Policy Affects Status Of Many FDA Cmte. Members

A "significant fraction" of current FDA advisory committee members' eligibility to vote and participate in meetings would be affected by a revised conflict of interest policy, FDA said





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts