regulatory

News

The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.

News

The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with MASH to help measure disease activity.

Oncology

Molecular recycling could transform the economics and innovation of oncology drug discovery.

News

The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies for chronic diseases to market more quickly.

News

FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.

News

Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.