Like most employers, the US Food & Drug Administration continues to try to balance in-person work with remote and hybrid options.
But when it comes to facility inspections, FDA has decided that in-person-only is the way to go, unless travel is...
US FDA continues to see in-person inspections as more efficient and more effective than ‘virtual’ alternatives. And that means that almost all domestic inspections will be handled by traditional site visits.

Like most employers, the US Food & Drug Administration continues to try to balance in-person work with remote and hybrid options.
But when it comes to facility inspections, FDA has decided that in-person-only is the way to go, unless travel is...
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.