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- Title
Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS.
- Authors
Kim, Jeanie; Ross, Joseph S.; Kapczynski, Amy
- Abstract
This Viewpoint uses the legal dispute between Amgen and the US Food and Drug Administration (FDA) regarding the FDA’s denial of market exclusivity for cinacalcet to discuss the FDA policy granting 6 months of market exclusivity as an incentive for manufacturers to conduct efficacy and safety studies in child populations.
- Subjects
UNITED States; AMGEN Inc.; UNITED States. Food &; Drug Administration; PEDIATRIC research; CHRONIC kidney failure in children; CLINICAL trials; THERAPEUTICS; ACTIONS &; defenses (Law); INDUSTRIAL laws &; legislation; MARKETING laws; PATENT law; CLINICAL trial laws; DRUG approval laws; GENERIC drugs; HYPERCALCEMIA; PEDIATRICS; GOVERNMENT regulation
- Publication
JAMA: Journal of the American Medical Association, 2018, Vol 319, Issue 1, p21
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2017.16477