High ratings could strengthen company financial performance, agency suggests. But stakeholders would need to understand the difference between site QMM and product quality for the incentives to work properly. More details to follow in upcoming workshop.
The Office of Pharmaceutical Quality in the US Food and Drug Administration’s Center for Drug Evaluation and Research 8 April laid out its case for rating industry on what the agency calls quality management maturity so that manufacturers will work harder to ensure a stable supply of quality pharmaceuticals.
The pitch made in the agency's new white paper on the topic is that high-quality pharmaceutical manufacturers would benefit from...
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.
