The White House ‘Biotechnology’ initiative is very broadly focused, with non-health sectors receiving the bulk of the attention. The US FDA’s role is small – but it could further boost attention to efforts to encourage adoption of advanced manufacturing.
The US Department of Health & Human Services is pledging $40 million to support biotech manufacturing of medicines as part of the implementation process for President Biden’s Executive Order launching a National Biotechnology & Biomanufacturing Initiative.
As part of its response to the 12 September order, HHS said it plans to “invest $40 million to...
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.
