8 March 2023
The U.S. Food and Drug Administration (FDA) announced a new funding opportunity for the FDA Rare Neurodegenerative Disease Grant Program to support efficient natural history studies and/or biomarker studies that fill unmet needs for rare neurodegenerative diseases for children and adults.
Through the support of prospective natural history and/or biomarker studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology and facilitate rare disease product development.
The FDA Rare Neurodegenerative Disease Grant Program was established by the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act. This program is administered by FDA’s Office of Orphan Products Development to promote medical product development for rare neurodegenerative diseases such as ALS.