US FDA Resumes China, India Inspections In Bid To Keep Drug Approvals On Schedule
Agency’s struggle to meet user fee commitments despite travel restrictions expected to worsen as pandemic continues into 2021.
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FDA’s remote assessment using documents Natural Beauty Care Pty provided led to a warning and an import alert. Melbourne area contract manufacturer responded to FDA request in April 2020, soon after agency stopped international inspections due to the coronavirus pandemic.
Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.
Alkermes CRL is just the latest fallout from black-hole process.