As market forces, seasonal flu and extreme weather cause US shortages of intravenous saline solutions to persist, providers writing in NEJM are heartened by idea that federal Homeland Security Department could step in to require manufacturing redundancies. Will industry solve the problem before it becomes a matter of national security?
Health care providers frustrated by intravenous saline shortages said they are encouraged by the possibility that the US government could step in to make pharmaceutical companies establish backup manufacturing facilities.
Although a key saline supplier was able to tap its international manufacturing network to reduce US shortages, questions remain about...
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.
