FDA has identified more than 40 high-priority drug products from at least five companies and is offering assistance to resume operations, including 'coordinating transport of certain critical drugs out of Puerto Rico.'
The sun had not yet risen on the ninth day after Hurricane Maria struck Puerto Rico and took out the island's electrical grid when FDA Commissioner Scott Gottlieb boarded an Air Force jet at Andrews Air Force Base as part of a delegation of high-level federal officials.
The delegation headed by Elaine Duke, the acting Homeland Security secretary, would reconnoiter the island with Puerto Rico Gov. Ricardo...
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.
