Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.
Regulatory authorities around the world are producing carefully worded notices in reaction to the discovery by Singapore’s Health Sciences Agency of a genotoxic nitrosamine impurity in a few formulations of the diabetes treatment metformin.
This marks the third chronic health condition long treated with medications now found to contain traces of the probable carcinogens,...
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.
