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  4. Designating an Orphan Product: Drugs and Biological Products
  5. Clinical Superiority Findings
  1. Designating an Orphan Product: Drugs and Biological Products

Clinical Superiority Findings

In accordance with section 527(e)(2) of the FD&C Act (21 U.S.C. 360cc(e)(2)), FDA will publish a summary of the clinical superiority findings when a drug is eligible for orphan-drug exclusivity on the basis of a demonstration of clinical superiority. This page will only include the clinical superiority findings for those drugs approved on or after August 18, 2017, the date that the FDA Reauthorization Act of 2017 added section 527(e)(2) to the FD&C Act. “Clinical superiority,” is used here only within the meaning of that term under FDA’s orphan drug regulations at 21 CFR Part 316 and section 527(c) of the FD&C Act. For the definition of “clinically superior,” for the purposes of determining eligibility for orphan-drug exclusivity when the same drug has been previously approved for the same use or indication, see 21 CFR 316.3(b)(3). For the definition of “same drug,” see 21 CFR 316.3(b)(14).

The summary is organized by approval date.







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