Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’
Six years after the first approval of a drug made using continuous manufacturing, the US Food and Drug Administration published a draft guidance to help drugmakers implement the process more widely.
The agency’s draft is identical to the International Council on Harmonization Q13 guidelines, but the guidance has been “reformatted and...
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.
