US FDA’s Inspection Volume Projected To Return To Normal Levels In FY 2022 As Backlog Looms
Additional hiring in FDA’s FY 2022 budget request also is expected to help address the inspections delayed by the coronavirus pandemic.
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The statement outlining opioid priorities in the FDA’s FY 2022 budget request comes on the heals of Sen. Manchin’s criticism of the acting commissioner and FDA opioid policy.
Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.
Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.