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

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

Internal US Food and Drug Administration documents on an application denial should not be offered to the sponsor if there are questions because the circumstances of the decision should not be a surprise, Center for Biologics Evaluation and Research Director Peter Marks told members of Congress.

During a 3 February House Energy and Commerce Health Subcommittee hearing on the FDA user fee reauthorization agreements, Rep. Neal...

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