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

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.

You may also be interested in...



Mis-Reading the Minutes: Arena Approval Follows Sell-Off Based on Advisory Committee Summary

Arena received great news June 27: approval of the weight loss therapy Belviq with a very clean label and no special marketing restrictions. That was what Wall Street expected—except when investors read the summary of the advisory committee review of the drug published by FDA on June 22.

The Inevitable Outcome: Diabetes Safety Model Expands To Weight Loss…And Beyond?

The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience – and what it might mean about regulatory expectations for other chronic drug classes in the future.

The Inevitable Outcome: Diabetes Safety Model Expands to Weight Loss…and Beyond?

The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience—and what it might mean about regulatory expectations for other chronic drug classes in the future.

Related Content

Topics

UsernamePublicRestriction

Register

PS080798

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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