The US FDA’s concerns about the transparency of the pharmaceutical supply chain surfaced in three recent drug GMP warning letters to drug repackers of active pharmaceutical ingredients who failed to disclose the names of the API manufacturers to their customers. Janet Woodcock, director of the agency's drug center, called such lack of transparency a "real threat" to public health that must be addressed quickly.
The US Food and Drug Administration recently issued three drug GMP warning letters to drug repackers of active pharmaceutical ingredients for omitting the name of the original manufacturers of the active pharmaceutical ingredients to customers, a common practice in the API sector that the agency wants to stop.
The three repackers were all in the US: B&B Pharmaceuticals in Englewood, CO; Asclemed USA, also known as Enovachem, in...
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.
