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

US FDA to explain why some approval decisions differ from advisory panel views

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration’s pledge as part of its transparency initiative to explain why it did not follow an advisory panel’s recommendations appears to extend only to those occasions when the agency approves a drug against a committee’s advice, and not when it rejects a new drug application or biologics licence application1,2.

Advertisement
Advertisement
UsernamePublicRestriction

Register

PS115290

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