Recent enforcement activities shed light on compliance challenges at ALI, UCB, Novo, Samsung, Nectar, Panacea and Beximco.
A focus on active pharmaceutical ingredients, data integrity and sterility assurance was evident in inspection reports, an untitled letter and a warning letter that the US Food and Drug Administration recently published, as well as a recent EU GMP noncompliance report.
The agency disclosed a drug GMP warning letter 31 October that focused on control of porcine ingredients for prescription hypothyroidism...
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.
