Can We Talk? US FDA Remote Records Review Missteps Worry Industry
Alkermes CRL is just the latest fallout from black-hole process.
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Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.
Alkermes’ combo pill for schizophrenia and bipolar disorder received an FDA complete response due to manufacturing questions that a physical site review might have resolved.
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.