US FDA officials grilled during first Senate Finance Committee hearing in months over practice of preannouncing foreign inspections.
Senators pressed US Food and Drug Administration officials on the need to strengthen oversight of foreign drug manufacturing quality at the Senate Finance Committee’s first hearing since COVID-19 hit the US several months ago.
Picking up at the 2 June hearing where Congress had left off before the coronavirus pandemic, they questioned the agency’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.
