FDA has issued final guidance that clarifies the types of technologies eligible for acceptance into the agency's Emerging Technology Program. FDA also issues internal guidance to explain how reviewers should handle emerging technology applications.
FDA’s final guidance on a program for encouraging the use of continuous manufacturing and other new pharmaceutical technologies clarifies the types of emerging technologies that are eligible for review under the agency's Emerging Technology Program.
The guidance also permits FDA's Office of Regulatory Affairs and the Office of Compliance in the agency's Center for Drug...
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.
