STAT June 1, 2024
CHICAGO — The Food and Drug Administration’s top oncologist reiterated that the agency doesn’t want drugmakers applying for approval with data from trials solely run in a single country such as China, but instead wants to see companies conducting studies across the world.
The comments by Richard Pazdur, director of the FDA’s Oncology Center of Excellence, came as more drugmakers report data from China, with Miami-based Summit Therapeutics earlier...