FDA pilot program to accelerate first-in-human trials gets input from Amgen, MSK, Cleveland Clinic on QRI roles, conflicts of interest, and oversight timelines.
To better combat China and Australia’s dominance in expediting early-phase trials, the FDA and stakeholders are ironing out the details of a pilot program to …
Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
FDA's CBER chief outlines a pilot to fast-track Phase 1 trials, pairing sponsors with vetted research institutions; applications…
Federal health officials aim to speed up drug development and better compete with China.
The FDA's new path, the status of animal testing, and other biotech news from The Readout
HHS launches clinical trial reforms — including new pilot programs and updated FDA guidance — to accelerate US drug development…
U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?
A series of newly planned reforms are designed to entice companies to start early trials in the U.S. rather than overseas.
