Inside Precision Medicine October 2, 2023
The U.S. FDA has launched the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program to speed up the development of therapies for rare diseases.
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products and Center for Drug Evaluation and Research (CDER) Office of New Drugs will invite selected organizations with rare disease therapy development programs to take part in the program.
The idea of the pilot is to add to and improve current communications between therapeutic product developers and the FDA to improve and speed up the approval process. Currently, meetings between product developers and the FDA during drug development are infrequent and formal, which can lead to development delays...
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