Administration proposal is long on ambition, short on details; goals are to confront future pandemics, including improving vaccines and therapeutics, manufacturing capacity and supply chains.
When politicians talk in “musts,” it is sometimes helpful to think in “coulds.” When an elected official or candidate says a plan must be enacted, the natural questions are, Could such an effort ever even be undertaken? And if it was, could it have the impact they promise?
The Biden Administration’s lengthy list of goals to ensure the country is prepared for the next pandemic is one such...
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.
