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NAVB Oldtimers Lounge
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Re: Head and NeckFound the answer on the FDA website Orphan Drug Definition An orphan drug is defined in the 1984 amendments of the U.S.Orphan Drug Act (ODA) as a drug intended to treat a condition affecting fewer than 200,000 persons in the United States, or which will not be profitable within 7 years following approval by the FDA. Incentives Orphan drugs are desperately needed by patients with rare diseases. The ODA provides for granting special status, orphan drug designation, to a product to treat a rare disease or condition upon request of a sponsor. The product to treat the rare diseaseor condition must meet certain criteria. Orphan designation qualifies the sponsor of the product for: -Seven-year marketing exclusivity to the first sponsor obtaining FDA approval of a designated drug -Tax credit equal to 50% of clinical investigation expenses -Exemption/Waiver of PDUFA application (filing) fees - Assistance in the drug development process - Orphan Products Grant funding |
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