Lexology September 4, 2025
The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. This ongoing release of CRLs follows the July 2025 creation of a public database for CRLs for drug and biologic applications that have been approved. To start this process, on Thursday, FDA posted 89 CRLs to its openFDA database. According to FDA, going forward, the agency will promptly publish newly issued CRLs for unapproved applications. FDA will also publish all CRLs for an application when approving an application, as well as batches of CRLs for abandoned or withdrawn applications. Below we summarize FDA’s announcement, and point out some of...
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