The Orphan Drug Act Revisited
Author:
Affiliation:
1. New York University School of Medicine, New York
2. Harvard Law School, Cambridge, Massachusetts
3. Division of Medical Ethics, NYU Langone Medical Center, New York, New York
Publisher
American Medical Association (AMA)
Subject
General Medicine
Link
https://jamanetwork.com/journals/jama/article-pdf/321/9/833/17770732/jama_thomas_2019_vp_190009.pdf
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1. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.;Downing;JAMA,2014
2. Estimated costs of pivotal trials for novel therapeutic agents approved by the US Food and Drug Administration, 2015-2016.;Moore;JAMA Intern Med,2018
3. There is no Parkinson disease.;Weiner;Arch Neurol,2008
4. Iqvia Institute. Orphan drugs in the United States. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/orphan-drugs-in-the-united-states-growth-trends-in-rare-disease-treatments.pdf. Published October 2018. Accessed January 5, 2019.
5. BagleyN, ChandraA, GarthwaiteC, SternAD. It’s time to reform the Orphan Drug Act. NEJM Catalyst. https://catalyst.nejm.org/time-reform-orphan-drug-act/. Published December 19, 2018. Accessed January 6, 2019.
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