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BioWorld - Sunday, December 14, 2025
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» US FDA finally taking the wraps off CRLs
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US FDA finally taking the wraps off CRLs
July 10, 2025
By
Mari Serebrov
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It’s been more than seven years in coming, but the U.S. FDA is at last making public at least some of the complete response letters (CRLs) it’s sent to drug and biologic sponsors to notify them of deficiencies in their approval applications.
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