US agency ensures pharmaceutical companies could manufacture critical medicines domestically even if cut off from China's API suppliers, while stockpiling pandemic medicines during pandemic with Baxter, Fresenius contracts.
The US government is stockpiling active pharmaceutical ingredients that could be used to manufacture essential medicines during a future pandemic or national emergency, adding a new layer of protection to the US pharmaceutical supply chain.
The US stockpile has been limited to medicines and medical supplies that could be shipped to places where health care...
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.
