US FDA will establish mandatory quality metrics reporting through a formal rulemaking process that could take years. Meanwhile, a revised draft guidance lays out plans for voluntary quality metrics reporting that could begin by January 2018.
FDA will require quality metrics reporting by rule rather than by guidance, the agency said Nov. 25 in revised draft guidance on its quality metrics program.
The revised draft establishes a pilot program stripped of controversial elements that will give FDA and the pharmaceutical industry practice...
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.
