Lexology September 11, 2025
On September 4, 2025, the U.S. Food and Drug Administration (“FDA”) announced plans to begin releasing complete response letters (“CRLs”) “promptly” after it issues them to sponsors, rather than waiting until after approval. Additionally, FDA released a batch of 89 CRLs for currently pending or withdrawn drug and biologic applications. The publication of CRLs relating to unapproved applications marks a significant departure from past FDA disclosure policy and raises potentially thorny legal questions. This client alert briefly describes FDA’s latest actions, the legal and policy issues they raise, and what to expect next.
FDA’s Announcement
FDA’s September 4 announcement appears to mean that, effective immediately, FDA will begin releasing any future CRLs promptly after issuing them to new drug application...
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