Pink Sheet is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

Just a Minute: The Final Step in Advisory Committee Process

This article was originally published in RPM Report

Executive Summary

FDA’s advisory committee process is a critical part of the new drug approval process. But the official record keeping of the committees is not: there is no real role for the “minutes” FDA publishes summarizing the panel deliberations.
Advertisement

Related Content

Mis-Reading the Minutes: Arena Approval Follows Sell-Off Based on Advisory Committee Summary
The Inevitable Outcome: Diabetes Safety Model Expands To Weight Loss…And Beyond?
The Inevitable Outcome: Diabetes Safety Model Expands to Weight Loss…and Beyond?
Setting the Stage: Qnexa and the Power of REMS
FDA Advisory Committees on the Brink: More Meetings, Fewer Members
Advisory Committee Reformers

Topics

Advertisement
UsernamePublicRestriction

Register

PS080798

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

Cancel