Import alert and warning letter came after Ningbo, China, over-the-counter skin care products firm failed to share requested testing records.
In the first of what could be many as pandemic travel restrictions continue, the US Food and Drug Administration on 22 January issued a drug good manufacturing practices warning letter to a company in China that was based on a remote records request rather than a site inspection.
It was 31 March 2020, two months after the FDA evacuated its China office and two weeks after it suspended...
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.
