Forthcoming 'guidance on guidance,' required under 21st Century Cures Act, should explain different ways that advocacy groups can get patient experience data in front of FDA and provide an opportunity for early interactions before groups go down the guidance development route.
The US FDA's forthcoming guidelines on how external groups can develop proposed draft guidance for agency consideration should discuss other ways for submitting patient experience data short of the formal guidance route, patient advocates said.
At a March 19 meeting convened by FDA, representatives from several advocacy organizations raised concerns that the agency's forthcoming draft...
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
