FDA Advisory Committees: independent, informed, essential and evolving

FDA

18 January 2017 - One of the most common concerns raised when I meet with medical leaders is the need to improve the function of FDA’s Advisory Committees. 

Advisory Committees play a key role in FDA’s decision-making process by providing independent expert advice on extraordinarily complex issues. Just as importantly, they offer a forum for open and transparent discussion about these processes. As their name suggests, Advisory Committees are only advisory, but they can yield unique insights into understanding the balance of benefits and risks of products.

Not every product is brought to an advisory committee — when the answers are clear, the FDA makes decisions without consulting an Advisory Committee. But when products present challenging issues or involve developing areas of science, the views of experts in relevant fields can provide essential perspective needed to make good decisions.

Read FDA Commissioner's blog

Michael Wonder

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Michael Wonder

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Medicine , US , Regulation