"FDA's Pilot Program Speeds Up Rare Disease Therapy Development"

The U.S. Food and Drug Administration (FDA) has launched a pilot program called Support for clinical Trials Advancing Rare disease Therapeutics (START) to accelerate the development of novel drug and biological products for rare diseases. The program allows a limited number of sponsors to have more frequent communication with FDA staff to address clinical development issues. Participants will receive advice and regular ad-hoc communication to address product-specific development issues. The program is open to sponsors of products currently in clinical trials under an active Investigational New Drug application (IND). The FDA aims to facilitate the development of potentially life-saving therapies for patients with unmet medical needs.