FDA’s quality metrics initiative emerges from hibernation with a two-part feedback program and a site visit program. The agency plans to collect feedback on quality metrics in certain meetings conducted during the application process – and in a pilot program. Agency staff also plan to visit firms to learn how they use quality metrics.
FDA on June 28 unveiled a package of initiatives designed to get the agency’s potentially revolutionary quality metrics initiative moving forward again.
The US regulatory authority had drafted guidance in July 2015 mandating the use of certain quality metrics but after encountering...
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.
