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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ANDA Sponsors Could Lose Exclusivity Because COVID-19 Prevented An Inspection … Or Not
US FDA will determine on a case-by-case basis whether its inability to inspect a facility because of the pandemic could result in 180-day exclusivity forfeiture for first generic filers.
US FDA's On-Time Review Decision Rates Slip During The Pandemic, Especially For Biosimilars
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.
US FDA Needs Plan For Addressing Inspection Backlog Post-COVID, GAO Says
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.