FDA commissioner underscores importance of restoring full production in Puerto Rico, where nearly 10% of all pharmaceuticals consumed in the US are made. Some plants have partially resumed operations under generator power, he notes, but the full recovery that at some point will be needed to prevent shortages will require restoring the island's power grid.
FDA Commissioner Scott Gottlieb has issued a statement reinforcing the agency's continuing commitment to helping restore Puerto Rico's medical products manufacturing base in the wake of hurricanes Irma and Maria.
It's important not just for the US territory but also for the entire nation, he said in an Oct. 6...
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.
