US FDA To Share Remote Assessment Findings And Mull Replies Before Issuing Complete Responses

 
• By Joanne S. Eglovitch

No more letters derailing applications over surprise drug GMP issues raised in remote records reviews, agency says. Now if sponsors get these CRLs, they will already know why.

Word on Folder Register of Card Index.
FDA's New Policy Aims For Transparency In Communicating GMP Problems Before CRL • Source: Shutterstock

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