BARDA terminates CIADM contract in wake of vaccine cross-contamination incident, begins discussion with industry about next steps for rapid pandemic response capabilities.
An early end to a troubled pandemic preparedness partnership between Emergent BioSolutions, Inc. and the US government’s Biomedical Advanced Research and Development Authority came last week as the agency prepared to turn the page on its COVID-19 pandemic response.
The partnership, one of BARDA’s two centers for innovation in advanced development and manufacturing, or CIADMs, was forged in 2012...
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.
