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FDA Orphan Drug Designation

Category: Biotech Service

Exhibitor: ONLY ORPHANS COTE LLC

Booth No: L724

Characteristic

The FDA ODD refers to a status granted by the U.S. FDA to a drug or biologic product intended to treat a rare disease or condition. The Orphan Drug Designation is part of the Orphan Drug Act, which was enacted in 1983 to incentivize the development of therapies for rare diseases. The benefits include 7-year market exclusivity, tax benefits, exemption from the PDUFA fee and exemption from PREA.

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