Infractions that have delayed Copaxone generic in plant Pfizer acquired when it bought Hospira suggest that pattern of quality issues may be continuing. Warning letter assigns eight tasks related to particulate contamination.
The US FDA's warning letter to Pfizer Inc. about a plant in McPherson, Kan., is the clearest indication yet that the quality problems the company acquired along with Hospira Inc.'s sterile injectables and biosimilars manufacturing capacity are continuing under its banner.
The agency found that the facility manufactured sterile injectable drug products that continued to contain visible particulates despite multiple complaint...
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.
