An approval delay Alkermes plc recently disclosed for its new schizophrenia and bipolar treatment, ALKS 3831, reflects communication challenges that have been a problem for drug makers ever since the US Food and Drug Administration suspended most site inspections in March due to the pandemic and began relying heavily on remote records reviews to assess manufacturing quality.
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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Alkermes CRL is just the latest fallout from black-hole process.
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