US FDA task force recommends a rating system that purchasers could rely on to reward manufacturers with robust management systems.
To avert the shortage of critically necessary medicines, the US Food and Drug Administration is proposing to rate pharmaceutical manufacturers on the basis of production quality. And although the criteria have yet to be determined, the hope is that payors would use the ratings to reward firms with better production systems.
This recommendation was one of three in the FDA’s interagency drug shortage task force report issued on 29 October....
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.
