The US FDA Commissioner acknowledged that the inspectorate has not been prepared for RWE, but as part of the revamp, a dedicated team will encourage its use “when it’s appropriate.”
The planned reorganization of the US Food and Drug Administration’s Office of Regulatory Affairs will include a program to train an inspection team to evaluate real-world evidence in the hopes of encouraging developers to use it, Commissioner Robert Califf said during an 11 September Friends of Cancer Research meeting.
Califf said “90-plus percent” of the inspectorate’s work “is either manufacturing or traditional clinical trials,” which he said, “goes extremely...
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
