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...
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”
An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
