Dasan didn't test glycerin for DEG; Akorn didn't see the problem with washed-vial conveyor belt crumbs; Evertogen was undone by a desk audit; six unsanitary compounders were warned; four firms were hit with drug GMP import alerts.
FDA on Sept. 22 issued a warning letter to Dasan E&T Co., an OTC maker of creams and soaps in Gimpo, South Korea, for inadequate testing of raw materials and poor control over the manufacturing process.
The firm did not test each lot of glycerin from a supplier for diethylene glycol (DEG) or ethylene glycol (EG)...
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.
