The FDA's Francis Godwin tells Pink Sheet of progress battling supply chain obfuscation, which could allow marketing of adulterated drugs; Yino warning letter is latest salvo.
A warning letter the US Food and Drug Administration recently sent to Yino Inc. of Chongqing, China, is the latest in a series of actions the agency has taken to protect US patients and consumers from certain quality risks associated with opaque pharmaceutical supply chains.
Francis Godwin, director of the Office of Manufacturing Quality in the FDA’s Center for Drug Evaluation and Research, told the...
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.
