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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.
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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
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