The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.
Worrisome findings as the US Food and Drug Administration finishes visiting never-before-inspected drug manufacturing facilities around the world helped drive a surge in warning letters in the fiscal year that ended 30 September, an agency official said.
These letters went to firms making over-the-counter drug products and targeted inadequate testing of raw materials and components, and failure...
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.
