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BioWorld - Thursday, June 18, 2026
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Home » 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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