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 misunderstandings that would...