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FDA to Amend Orphan Drug Regulations

10/19/2011

Federal Register Proposed rule: FDA is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act to clarify regulatory provisions and make minor improvements. FDA addresses issues such as (1) demonstration of an appropriate “orphan subset” of persons with a particular disease or condition that otherwise affects 200,000 or more persons in the U.S., for the purpose of designating a drug for use in that subset; (2) eligibility for orphan-drug designation of a drug that is otherwise the same drug for the same orphan indication as a previously approved drug; (3) eligibility for multiple orphan-drug exclusive approvals when a designated orphan drug is separately approved for use in different subsets of the rare disease or condition; (4) requirement for demonstrating clinical superiority for the purpose of orphan-drug exclusive approval. To view this proposed rule, click here.

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