FY 2023 appropriations language requires HHS Secretary to designate advanced manufacturing technologies for expedited review, and to follow up with advice and meetings that could help move things along.
The US fiscal year 2023 omnibus spending package that President Biden signed into law 29 December promises to expedite reviews of drugs and biologics that sponsors plan to manufacture using advanced technologies.
Section 3213 of the legislation adds a Section 506L to the Food, Drug & Cosmetic Act that could expedite review...
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.
