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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Records From Down Under Put Personal Care Product Provider Under US Regulatory Thumb
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.
Preparing For The Return Of US FDA Inspections
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.
Can We Talk? US FDA Remote Records Review Missteps Worry Industry
Alkermes CRL is just the latest fallout from black-hole process.