MedCity News September 4, 2025
FDA Commissioner Marty Makary said publishing complete response letters recognizes public interest in the transparency and credibility of agency decision-making about drugs. He also said the move complies with an executive order that covers the communication of scientific data.
The next time the FDA turns down a drug application, the letter outlining the decision and the regulator’s reasoning will become public record. The agency said it will release future complete response letters (CRLs) “promptly after they are issued to sponsors.”
The Thursday announcement follows the FDA’s July move to publish more than 200 letters from 2000 to 2024 as part of its pledge for greater transparency. Along with pledging to publish all CRLs going forward, the FDA said in its...
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