Pharmaceutical companies struggling to keep up with coronavirus-related supply chain havoc asked to keep the US regulator informed as situation unfolds.
During the rest of the COVID-19 pandemic, pharmaceutical companies should update the US Food and Drug Administration about manufacturing interruptions every two weeks even if nothing has changed or if the interruptions are not meaningful, according to agency guidance that took effect immediately upon its 31 March issuance.
Like other COVID-19 guidance, the FDA issued this one as a final document, dispensing with the customary practice of considering...
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.
