U.S. Food and Drug Administration

Office of Orphan Products Development

The Office of Orphan Products Development (OOPD) is dedicated to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions since 1982. OOPD interacts with the medical and research communities, professional organizations, academia, and the pharmaceutical industry, as well as rare disease groups. The OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases. The ODA has been very successful - more than 200 drugs and biological products for rare diseases have been brought to market since 1983. In contrast, the decade prior to 1983 saw fewer than ten such products come to market. In addition, the OOPD administers the Orphan Products Grants Program which provides funding for clinical research in rare diseases.

Designating an Orphan Product: Drugs and Biologics

Designating a Humanitarian Use Device(HUDS)

Orphan Product Grants

Frequently Asked Questions (FAQ)

Other Sources of Rare Disease/Orphan Products Information

Federal Register Regulations

Tax Credit

Medical Device legislation

Tips on Submitting an Application for Orphan Designation