House lawmakers who get the first cut at setting the FDA’s budget joined GAO expert in raising concerns about shortage of investigators and lack of surprise for foreign inspections.
House appropriators pressed a General Accountability Office expert at a 9 March hearing to elaborate on concerns raised in a recent GAO report on a shortage of US Food and Drug Administration staff trained to conduct foreign inspections and on a lack of parity between foreign and domestic FDA inspections due to prior notification going to foreign firms.
These concerns, and the hearing, stem from a recent GAO report on how the pandemic has adversely impacted the FDA’s...
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.
