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...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
