Ranitidine no more carcinogenic than grilled meat, the FDA’s Woodcock says, with NDMA levels well below those claimed by Valisure.
Based on its test results to date, the US Food and Drug Administration 1 November again refrained from calling for consumers and patients to stop taking ranitidine products due to concerns about nitrosamine impurities that could cause cancer.
Agency tests found the N-Nitrosodimethylamine (NDMA) nitrosamine impurity in a range of oral solid and oral liquid dosage forms from...
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.
