Subjects: Orphan Drug Production / Genre: Technical Report - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Orphan Drug Production ✖ Genre Technical Report ✖

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

Publication:: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
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.

2. FDA oversight

Author(s):: White, Robert S., author
Publication:: [Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):: Drug Approval
Drug Therapy
Government Regulation
Orphan Drug Production
Rare Diseases -- drug therapy
Humans
United States
United States. Food and Drug Administration.

3. Orphan drugs: FDA could improve designation review consistency; rare disease drug development challenges continue : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, November 2018
Subject(s):: Drug Approval
Orphan Drug Production
United States
United States. Food and Drug Administration.