News
HHS and FDA propose clinical trial reforms to expedite drug development
Overview
The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for investigational new drug (IND) submissions to FDA.
The two key initiatives were announced as part of a broader program by the Department of Health and Human Services (HHS) called “Operation Trailblazer.” The program includes a series of measures designed to speed up drug development from the IND stage to late-stage clinical trials.
In This Article
Call for action and comments: Expedited IND pilot by July 22, QSP guidance by July 24, substantial-evidence guidance by August 24.
The Big Picture
With the FDA’s initative to bring early clinical research back onshore, New York’s institutions are the natural partners-of-record. The state hosts the world’s largest concentration of academic medical centers, runs more than a quarter of all U.S. clinical trials, graduates more life-science PhDs than any region, and supports 75,000+ biotech jobs.
