Alkermes CRL is just the latest fallout from black-hole process.
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...
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.
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.
Alkermes CRL is just the latest fallout from black-hole process.
Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
