FDA Launches Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program

On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics Evaluation and Research (“CBER”) and Center for Drug Evaluation and Research (“CDER”), was designed to “help further accelerate the development of novel drug and biological products for treatment of rare diseases.”…
By: Goodwin