A dashboard tool US FDA is developing promises to liberate key information from the agency’s trove of CMC review documents, enabling greater consistency among reviews and a greater emphasis on the manufacturing issues that pose the greatest risks.
FDA is working to establish a digital dashboard tool that will help the agency compare drug products by therapeutic area, particularly generics of the same reference-listed drug, in an effort to more appropriately manage product-related quality risks.
The agency is building the dashboard on a system it has used over the past two years to focus chemistry,...
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.
