After import alerts to five facilities in China, Austria, and Australia, US FDA follows up with warning letters; meanwhile, another firm in China receives notice of non-compliance with EU GMP requirements.Shanwei Honghui, Wuham Moxibustion, Yicheng Chemical, Schrofner Cosmetics, Delta Labs, and Inner Mongolia Changsheng among firms now in regulatory cross hairs.
FDA sent a warning letter Dec. 5 to Shanwei Honghui Daily Appliance Co. in Shanwei, China, for failing to test drug products released to the US market and for having dirty equipment.
The firm had no test records to support the release of the drugs to the US market. The firm’s engineer...
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.
