Day: August 21, 2025

Medical technology is advancing faster than ever, but many lifesaving devices often face years of regulatory hurdles before reaching patients. The FDA’s Breakthrough Devices Program is designed to change that, offering innovators a faster pathway to market while maintaining rigorous safety standards. With over 1,100 designations and 160 authorizations to date, this program is transforming … Read more

In cancer research, nothing is more important than proving whether a treatment helps patients live longer. That’s why “overall survival” (OS) is considered the gold standard in oncology trials—it’s clear, objective, and clinically meaningful. The FDA’s new draft guidance sheds light on how sponsors should design, analyze, and report OS data to ensure that cancer … Read more