Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases
Guidance for industry
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.
Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Orphan Drug Production
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
The National Library of Medicine believes this item to be in the public domain.
1 online resource (1 PDF file (6 pages)).
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