The FDA posted this guidance on 11Sep25. The guidance describes three Alternative Tools that were successfully used during Covid that the Agency will continue to employ as part of pre-approval assessments of drug manufacturing facilities:
"• Requesting records and other information, pursuant to section 704(a)(4) of the FD&C Act (21 U.S.C. 374(a)(4)), directly from facilities and other entities subject to inspection17
• Performing remote interactive evaluations (RIEs) (e.g., remote livestreaming video of operations, teleconferences, screen sharing)
• Requesting existing inspection reports and other information from trusted foreign regulatory partners through mutual recognition agreements and other agreements"
The use of these tools will be with a risk-based set of considerations that include the past inspection history of the facility.
The posting and link to the guidance are here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/alternative-tools-assessing-drug-manufacturing-facilities-identified-pending-applications?utm_medium=email&utm_source=govdelivery
#fda #AssessingMFGFacilities #AlternativeTools
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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