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  4. Grant Programs to Support Development of Medical Products for Rare Diseases
  5. Orphan Products Grants Program
  1. Grant Programs to Support Development of Medical Products for Rare Diseases

Orphan Products Grants Program

FDA Office of Orphan Products Development (OOPD)

The FDA Office of Orphan Product Development (OOPD) administers several grant programs that provide incentives to promote and accelerate the development of innovative products for the treatment, prevention and diagnosis of rare diseases. 

Orphan Products Grants Program

The Orphan Drug Act (ODA) enacted by Congress in 1983 provides incentives to defray the costs of developing drugs, biologics, devices, and medical foods for rare diseases or conditions. The Orphan Products Grants Program awards grants to clinical investigators to support the development of safe and effective medical products (drugs, biologics, medical devices, and foods for medical purposes) for patients with rare diseases or conditions.

Rare diseases are statutorily defined as those affecting fewer than 200,000 persons in the United States. Although there are over 7,000 rare diseases that affect more than 30 million Americans, prior to the incentives established by the ODA, there was little market interest in developing medical products for rare diseases.

  • Clinical Trials Grants Program - Funds clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions (since 1983). Learn more and view grants awarded. 

  • Natural History Studies Grants Program - Funds well-designed, protocol-driven natural history studies that address knowledge gaps, support clinical trials, and advance rare disease medical product development (since 2016). Learn more and view grants awarded. 

Additional Rare Disease Grants

  • OOPD also administers the FDA Rare Neurodegenerative Disease Grants Program. Established by the ACT for ALS Act in 2021, this program awards grants and contracts to cover the costs of research and development of interventions intended to prevent, diagnose, or treat amyotrophic lateral disease (ALS) and other rare neurodegenerative diseases in adults and children (since 2022). 

 


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