NLM Digital Collections

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
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
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