The US FDA requests several manufacturers recall extended-release metformin based on studies confirming a higher NDMA impurity threshhold; previous testing found no significant risks.
The US Food and Drug Administration is advising that certain extended-release formulations of metformin made by five manufacturers have high levels of the potential carcinogen N-Nitrosodimethylamine (NDMA) and has requested these products be recalled. Earlier evaluations led the agency to conclude these products posed negligible cancer risks.
Valisure, the online pharmacy that challenged the agency's initial test findings, asserts that the FDA continues to underestimate the carcinogenic...
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.
