Pandemic Taking Its Toll On The US FDA’s Non-Pandemic Work, Alkermes CEO Says
Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.
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With more experience, the US FDA was able to standardize record review requests and timing.
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.
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.