Was backdating of GMP records part of an effort to move suspect product? FDA investigators found Sun was leaving lots of stones unturned in its effort to find out.
A pharmaceutical manufacturing plant in northern India that the US Food and Drug Administration subjected to an import alert and consent decree a decade ago is under a cloud once again now that the agency has disclosed new inspection findings.
Whether the latest findings lead to additional enforcement actions depends in part on how the plant's current owner, Sun...
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.
