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Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS.
- Source :
- JAMA: Journal of the American Medical Association; 1/2/2018, Vol. 319 Issue 1, p21-22, 2p
- Publication Year :
- 2018
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00987484
- Volume :
- 319
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- JAMA: Journal of the American Medical Association
- Publication Type :
- Academic Journal
- Accession number :
- 127132311
- Full Text :
- https://doi.org/10.1001/jama.2017.16477