A revolution on the way? The new move that will accelerate drug development in the US

The US Food and Drug Administration (FDA) has launched a new pilot program, the Expedited IND Pilot, aimed at shortening the preparation time for first-in-human trials, which can currently take up to two years. The program will connect drug companies with research institutions that have regulatory expertise and allow for a phased review of applications. In the first phase, eight to ten collaborations will be selected.

The US Food and Drug Administration (FDA) has launched a new pilot program called the Expedited IND Pilot, designed to shorten the path from a drug discovery in the lab to the start of its first human trial. According to the FDA, preparations for initial trials in the US can currently take up to two years, a period that can delay medical developments before their safety in humans has even been tested. The program will connect drug-developing companies with research institutions that have scientific and regulatory expertise, which will help companies prepare the required applications to obtain approval to start a clinical trial. In the first phase, eight to ten collaborations between companies and research institutions are expected to be selected. Under the pilot, the FDA will be able to review components of the application gradually, even before the entire file is completed, with the aim of identifying scientific gaps or safety concerns in real time. The program will also encourage early coordination between the company, the research institution, the ethics committee, and the trial sites. The FDA emphasizes that the program is intended to streamline work, not to reduce scientific or safety requirements, and that the agency will maintain its full oversight authority. At this stage, this is a limited pilot, not a sweeping change to the US trial approval process.