FDA Office of Orphan Products Development logo
Funder · Federal agency

FDA Office of Orphan Products Development

Funds rare disease treatment development by supporting clinical studies, natural history research, and pediatric medical device development.

United Stateswww.fda.gov
Key stats
Annual funding$23M
Programs4
Active grants1
Total grants4
About

The FDA Office of Orphan Products Development is a federal office inside the US Food and Drug Administration and the Department of Health and Human Services. It funds clinical research for rare diseases, defined here as conditions affecting fewer than 200,000 people in the United States, and its annual grant budget is about USD 23 million.

The office runs three grant programs: Orphan Products Gra…

Programs & grants under this funder
Orphan Products Natural History Studies Grants Program

Supports grants for protocol driven natural history studies that fill knowledge gaps and enable clinical trials in rare diseases.

1 grant
Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases
Open
— pool·534 days
Orphan Products Clinical Trials Grants Program

Supports style grants for clinical trials drugs, biologics, devices, and medical foods in rare diseases.

1 grant
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases
Between cycles
$5M pool
Pediatric Device Consortia (PDC) Grants Program

Supports Grants to nonprofit consortia that provide regulatory, business, and device development services to pediatric medical device innovators.

1 grant
Pediatric Device Consortia Grants Program
Between cycles
$6M pool
FDA Rare Neurodegenerative Disease Grants Program

Supports Clinical trial grants and contracts for ALS and other rare neurodegenerative diseases in adults and children.

1 grant
Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases
Between cycles
— pool
Parent entityFDA — Food and Drug Administration
Last verified: 29 May 2026Source: www.fda.gov