FDA Avoided Half Of ANDA Pre-Approval Inspections During COVID By Using Alternative Tools
Records reviews are common now in lieu of an in-person inspection for US generic applications, but more virtual facility checks could be coming soon.
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Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.
ORA continued to spend user fee dollars despite its inability to travel for facility inspections, while CBER found little generic and biosimilar work during FY 2020.
Additional hiring in FDA’s FY 2022 budget request also is expected to help address the inspections delayed by the coronavirus pandemic.