Unannounced Foreign Drug Inspection Pilot, Other US Inspection Measures Enacted
A suite of pharmaceutical inspection measures stripped from the user fee renewal legislation were added to the US FY 2023 spending law, including provisions for new inspection priorities, remote alternatives, mutual reliance, internal FDA coordination and unannounced foreign inspections.
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Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.
Inspection subsection would penalize high-quality sites in low-quality foreign regions with greater inspection frequency, while adding more surprise inspections and requiring greater internal US FDA coordination to prevent quality issues from causing drug shortages.
Measures aimed at spurring biomedical innovation, ensuring fewer roadblocks to development of biosimilars and generics, and strengthening the FDA’s interactions with rare disease patients could find their way into must-pass legislation reauthorizing the human drug and biologic user fee programs by 30 September.