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# Guide on Certain Pediatric Orphan Designations
- URL: https://www.fdaweb.com/guide-on-certain-pediatric-orphan-designations/
- Published: 2018-07-27T12:00:00.000Z
- Updated: 2026-09-15T00:22:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141982

*Federal Register* notice: FDA has made available a final guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” The agency says it does not expect to grant any additional orphan-drug designations to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). This, it says, will help resolve an unintended loophole in the Pediatric Research Equity Act orphan exemption process. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-27/pdf/2018-16027.pdf?ref=fdaweb.com).