The USP has launched an initiative to address the nitrosamine crisis by proposing a new general chapter that outlines a set of analytical methods that manufacturers can use to demonstrate their products are free from unsafe levels of these potential carcinogens. The chapter is aligned with the FDA’s guidance on nitrosamine impurities.
The USP has proposed guidance on how to test active pharmaceutical ingredients and drug products for nitrosamine impurities, which have been discovered in a growing array of blood pressure medications and other pharmaceuticals.
The USP general chapter was proposed the day the US Food and Drug Administration issued guidance on controlling nitrosamines in...
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.
