COMPETES Act also includes enhanced penalties for drug makers who falsify or destroy records, power for the FDA to recall harmful drugs, funding for drug manufacturing technology and additional supply chain flexibility efforts.
Legislation that cleared the US House 4 February would support a drug supply chain "elasticity" pilot project to show how critical supplies could expand when demand soars like it has with the COVID-19 pandemic, and then shrink back afterward. While the initiative is designated as a pilot, it would receive significant funding: $1.5bn.
Enhancing this kind of flexiblity is a big riddle that next-pandemic planners will have to solve. (Also see "Consortium...
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.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.
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.
