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- Title
Pediatric Drug Trials Facing Some Obstacles.
- Authors
Finkelstein, Joel B.
- Abstract
The article reports on the hindrances regarding the attempts to conduct federally mandated studies of newly approved oncology drugs in children in the U.S. Gregory Reaman, chairman of the Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee's pediatric subcommittee reveals the lack of early communication in the planning and consideration of the studies. Pharmaceutical companies are also facing problems in complying with the Pediatric Research Equity Act. FDA officials agree that the law has been important in getting pediatric research off the ground.
- Subjects
UNITED States; CLINICAL trials; PEDIATRIC research; RESEARCH laws; TUMORS in children; ONCOLOGY
- Publication
JNCI: Journal of the National Cancer Institute, 2005, Vol 97, Issue 23, p1720
- ISSN
0027-8874
- Publication type
Article
- DOI
10.1093/jnci/dji441