After Melbourne, Florida, outsourcer resisted entreaties to recall sterile drugs over contamination and eye infections, the FDA warned consumers not to use sterile drugs compounded by the firm, Pacifico National, doing business as AmEx Pharmacy.
The US Food and Drug Administration issued a formal request to AmEx Pharmacy to recall its sterile drug products after finding they pose a "serious health hazard" after an inspection revealed numerous good manufacturing practice violations.
A few days after issuing a formal request to Pacifico National, doing business as AmEx Pharmacy, to recall sterile...
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.
