The US Food and Drug Administration (FDA) is weighing up potential changes to its advisory committees (ACs) and their role in making decisions on pharmaceutical and other products.
Robert Califf, the FDA Commissioner, wrote in a blog piece that the need to improve the function of the ACs is “one of the most common concerns raised” when he meets with medical leaders.
“ACs play a key role in FDA’s decision-making process by providing independent expert advice on extraordinarily complex issues,” Dr Califf wrote. “Just as importantly, they offer a forum for open and transparent discussion about these processes. As their name suggests, ACs are only advisory, but they can yield unique insights into understanding the balance of benefits and risks of products.”
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze