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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

The US Food and Drug Administration said 1 February it will share information about manufacturing deficiencies identified in remote records reviews conducted in lieu of or in advance of pre-approval and pre-license inspections and will consider sponsors’ responses to the findings.

The agency may later expand the policy to include records reviews conducted in lieu of or in advance of surveillance inspections.

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