Regulatory Open Forum

I wanted to see I could gauge what some people have been seeing in terms of when the FDA is inspecting clinical sites associated with participating in clinical studies being used to support NDA/BLAs.  What average timeframe have you been seeing the FDA doing inspections in relation to when the NDA/BLA was submitted (ex: 4 months after)?  We are seeing some variability among this timeframe and between if it is a NDA vs a BLA and just wanted to see if others are seeing more consistent time frames.

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Lauren Wallace RAC
Director of Clinical Research Regulatory Affairs
Virginia Commonwealth University
Richmond VA
United States
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Recent experience (NDA and Supplement) is BIMO inspections start almost immediately after the 60-day filing date. Sooner vs later may depend on factors such as regular vs priority review, site location, etc.

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Glen Park PharmD
Consultant
Burien WA
United States
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Original Message:
Sent: 12-Jun-2024 07:45
From: Lauren Wallace
Subject: Bioresearch monitoring- FDA inspections

I wanted to see I could gauge what some people have been seeing in terms of when the FDA is inspecting clinical sites associated with participating in clinical studies being used to support NDA/BLAs.  What average timeframe have you been seeing the FDA doing inspections in relation to when the NDA/BLA was submitted (ex: 4 months after)?  We are seeing some variability among this timeframe and between if it is a NDA vs a BLA and just wanted to see if others are seeing more consistent time frames.

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Lauren Wallace RAC
Director of Clinical Research Regulatory Affairs
Virginia Commonwealth University
Richmond VA
United States
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