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

 
• By Bowman Cox

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

Bad communication speech bubble sign
remote communication found lacking • Source: Shutterstock (mine chuenmanuse)

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.

Industry officials say it has been difficult to put requested records into the proper context for the agency, and that delayed feedback has slowed the resolution of

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Non-Compendial Product Quality Screening Draws US FDA’s Criticism

 
• By Bowman Cox

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

Non-Compendial Product Quality Screening Draws US FDA’s Criticism

 
• By Bowman Cox

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

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

 
• By Bowman Cox

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

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