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.
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But the commissioner also said proponents of releasing CRs may be making too much of the idea, because there are few CRs actually issued.
Rep. Dunn’s idea would be a return to prior agency practice; the documents are currently considered exempt from disclosure.
The bill, some version of which is undoubtedly destined for the FDA user fee package, also would codify existing labeling guidance for products cleared through the pathway.