# Clarification of Orphan Designation of Drugs and  Biologics for Pediatric Subpopulations of Common Diseases:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/clarification-of-orphan-designation-of-drugs-and-biologics-for-pediatric-subpopulations-of-common-diseases-guidance-for-industry/254d968c-50ac-46d1-9627-0b4e065111ba

> FDA guidance document: Clarification of Orphan Designation of Drugs and  Biologics for Pediatric Subpopulations of Common Diseases:  Guidance for Industry. Issue date: December 19, 2017. Get complete insights and analysis.

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## Details

- Title: Clarification of Orphan Designation of Drugs and  Biologics for Pediatric Subpopulations of Common Diseases:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2017-12-19
- Comment Close Date: 2018-07-27
- Last Changed: 2024-04-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-6380.">FDA-2017-D-6380.</a>

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