Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Collection: Health Policy and Services Research Series Title(s): Guidance for industry Contributor(s): United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. FDA Office of Orphan Products Development, issuing body. Publication: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018 Language(s): English Format: Text Subject(s): Drug Approval Orphan Drug Production Pediatrics United States United States. Department of Health and Human Services United States. Food and Drug Administration Genre(s): Guideline Technical Report Copyright: The National Library of Medicine believes this item to be in the public domain. (More information) Extent: 1 online resource (1 PDF file (6 pages)). NLM Unique ID: 101734398 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101734398