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 Along with pledging to publish all CRLs going forward, the FDA said in its latest announcement that 89 previously unpublished letters issued from 2024 to the present have been published. The agency said each letter details specific safety and efficacy deficiencies that prevented an FDA approval.

Companies have generally opposed publishing of CRLs. Besides not wanting a public

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