Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.
US and EU regulatory authorities are investigating findings by an online pharmacy that brand and generic versions of the antacid Zantac (ranitidine) contain dangerous levels of one of the carcinogenic nitrosamine impurities found last year in certain blood pressure medications.
Valisure LLC, New Haven, CT, in September 2018 launched what it says is the first online pharmacy that validates every...
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.
