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US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows

 
• By Joanne S. Eglovitch

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

in-person inspections
Industry is eager for the return to in-person inspections, and the US FDA is tweeting all the right things. • Source: Shutterstock

Perhaps sensing the pharmaceutical industry’s growing irritation with the US Food and Drug Administration’s inability to perform timely onsite inspections and complaints about its use of remote assessments, FDA Commissioner Stephen Hahn has reiterated that the agency has resumed performing domestic inspections.

Hahn announced in a 23 November tweet that “we have resumed prioritized domestic surveillance inspections and are using all available tools and sources of information to support regulatory decisions on applications

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