BARDA’s consortium approach scrutinized as industry recovers from US Defense Production Act rated orders. Questions of sustainment fees, interruptible commercial activities explored during BioMaC Industry Day call as agency emphasizes need for proven capacity.
Still smarting from the frustration of scaling up their limited pandemic response capabilities to produce COVID-19 vaccines and therapeutics, officials with the US government’s Biomedical Advanced Research and Development Authority, or BARDA, shared insights on a 20 January call regarding the industry input sought to help them decide how to prepare for future pandemics.
The emerging concept is to establish some type of industry consortium that would always be at the ready with facilities...
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.
