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Can We Talk? US FDA Remote Records Review Missteps Worry Industry

Executive Summary

Alkermes CRL is just the latest fallout from black-hole process.

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US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows

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.

Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections

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.

US FDA Assesses Over 500 Biopharma Plants Remotely Via Records Review; Refines Process

Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.

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