Agency’s proposals for pandemic preparedness reauthorization would build on CARES Act provisions to gain greater visibility into global pharmaceutical supply chains, while also seeking deeper understanding of manufacturing quality management activities. Also included in FY 2024 budget request: long-sought drug destruction and drug recall authorities.
If the US Food and Drug Administration gets its way, pandemic response legislation that expires this year would be reauthorized with a set of provisions that help the agency see more deeply into pharmaceutical supply chains and help make sure they deliver enough quality products to meet demand.
As part of its fiscal year 2024 budget submission, the agency outlined eight drug-related legislative proposals for the next...
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.
