US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies
Agency's Janet Woodcock and Judy McMeekin say the FDA is looking at options like livestream plant videos while preparing to address backlog after inspections can resume.
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Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.
Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.
FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.