Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.
The US Food and Drug Administration is having internal discussions about whether domestic surveillance inspections should continue to be pre-announced after the COVID-19 public health threat subsides, which would put them on par with foreign sites that are given such notice, said a high-level FDA enforcement official.
Alonza Cruse, who is the director of the Office of Pharmaceutical Quality Operations in the FDA Office Of Regulatory Affairs,...
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.
