FDA Launches START Pilot Program to Help Accelerate Development of Rare Disease Therapies
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FDA Launches START Pilot Program to Help Accelerate Development of Rare Disease Therapies
FDA is taking steps to help further accelerate the development of novel drug and biological products for rare diseases. Today, the agency is announcing the opportunity for a limited number of development programs to participate in the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program. Selected participants of the START Pilot Program will receive more frequent advice and increased communication with FDA staff to address product-specific development issues including but not limited to clinical study design, choice of control group and finetuning the choice of patient population.  The FDA will be accepting applications to the START Pilot Program between January 2, 2024, and March 1, 2024. CDER will consider applications from development programs for novel drug products intended to treat rare neurodegenerative conditions (including those of rare genetic metabolic etiology).  For more information, including the full pilot program criteria, please visit FDA Launches Pilot to Help Further Accelerate Development of Rare Disease Therapies.
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