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Rare Neurodegenerative Disease Grants Program is sponsored by U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD). This program awards grants and contracts for research and development of interventions to prevent, diagnose, mitigate, treat, or cure rare neurodegenerative diseases in adults and children.
While urea cycle disorders are metabolic, they can have significant neurological impacts, making this potentially relevant.
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Office of Orphan Products Development | FDA Skip to in this section menu Office of the Commissioner Office of the Chief Medical Officer Office of Orphan Products Development Office of the Chief Medical Officer The FDA Office of Orphan Products Development (OOPD) supports and advances the development and evaluation of new treatments for rare diseases.
OOPD evaluates information from product sponsors to determine if drugs, biologics or medical devices meet the criteria for certain incentives and administers grants to provide funding for research on rare diseases. The office also works on rare disease issues with medical and research communities, professional organizations, academia, government agencies, industry and rare disease patient groups.
Work with sponsors to determine if their products meet the criteria for certain categories (e.g., orphan drug, rare pediatric disease drug or humanitarian use device designations).
Provide orphan status to drugs and biologics which are intended to treat, diagnose or prevent rare diseases that affect fewer than 200,000 people in the U.S. Designate medical devices that intend to benefit patients in treating or diagnosing a disease or condition that affects fewer than 8,000 individuals in the U.S. per year.
Work with the Office of Pediatric Therapeutics and product centers to determine rare pediatric disease designation for drugs or biologics that meet certain criteria. Sponsors of such product applications may qualify for a priority review voucher, which can be redeemed to receive a priority review of a subsequent marketing application for a different product.
Award grants to provide funding for clinical trials and natural history studies that advance rare disease medical product development. Award grants that provide funding to develop nonprofit consortia to facilitate pediatric medical device development.
Awards grants and contracts to use in the development of tools, methods and processes to characterize the natural history of rare neurodegenerative diseases , to identify molecular targets for these diseases, and to increase efficiency and productivity of new treatment development. Email: orphan@fda. hhs.
gov Office of Orphan Products Development Office of the Chief Medical Officer U.S. Food and Drug Administration 10903 New Hampshire Ave. WO-32, Room 5295 Designating an Orphan Product: Drugs and Biological Products Humanitarian Use Device Program Rare Pediatric Disease Program Grant Programs to Support Development of Medical Products for Rare Diseases Pediatric Device Consortia Grants Program
According to the current listing, eligibility includes: Not explicitly stated in the provided snippets, but generally for researchers and entities developing interventions for rare neurodegenerative diseases. Confirm the full requirements in the official notice before applying.
Rare Neurodegenerative Disease Grants Program is funded by U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD). Verify program details on the funder's official page before applying.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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