The White House is playing up a new initiative to support ‘biotechnology and biomanufacturing.’ The focus on innovation is always a welcome theme – but it does not signal any change in the emphasis on cutting drug pricing in the Biden Administration.
The Biden Administration is launching a new National Biotechnology & Biomanufacturing Initiative designed to encourage investment in biotechnology via an executive order signed by the President on 12 September.
“This initiative will grow the strength and diversity of domestic biomanufacturing capacity, expand market opportunities for bio-based products through the...
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.
