The FDA has launched the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) program, applying lessons from the operation that rapidly developed COVID-19 vaccines. The program aims to expedite research and development for rare diseases by helping companies navigate clinical development issues, such as study design and patient population. Participating companies will benefit from FDA guidance and advice, aiming to accelerate the regulatory process for new rare disease therapies. The program is open to companies with products under an Investigational New Drug application that treat rare neurodegenerative diseases. Applications will be accepted from January 2, 2024, until March 1.
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[Source: MM+M, November 22nd, 2023]