Complete Response Letters: US FDA Tells Congress Broader Disclosures To Sponsors Could Be ‘Chilling’

 
• By Derrick Gingery

A lengthy hearing that addressed everything from Aduhelm to advanced manufacturing serves as the formal kick off of the user fee reauthorization season and offers a preview of many possible FDA reforms that House members could seek to include in the legislation.

Rep. Neal Dunn, R-FL, questions CBER Director Peter Marks
Rep. Neal Dunn, R-Fla., questions CBER Director Peter Marks during a House Energy and Commerce Health Subcommittee hearing on the new FDA user fee agreements. • Source: Screenshot

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