Aaron S. Kesselheim, MD, JD, MPH; Thomas J. Hwang, AB
Disclaimer: The views expressed in this article are solely those of the authors.
Acknowledgment: The authors thank Ameet Sarpatwari, JD, PhD, for his comments on an earlier draft.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1906.
Requests for Single Reprints: Aaron S. Kesselheim, MD, JD, MPH, Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, email@example.com.
Current Author Addresses: Dr. Kesselheim: Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120.
Mr. Hwang: Bain Capital Ventures, 200 Clarendon Street, Boston, MA 02116.
Author Contributions: Conception and design: A.S. Kesselheim, T.J. Hwang.
Analysis and interpretation of the data: T.J. Hwang.
Drafting of the article: A.S. Kesselheim, T.J. Hwang.
Critical revision of the article for important intellectual content: A.S. Kesselheim, T.J. Hwang.
Final approval of the article: A.S. Kesselheim, T.J. Hwang.
Provision of study materials or patients: T.J. Hwang.
Collection and assembly of data: T.J. Hwang.
Table. Comparison of Breakthrough Drug and Device Programs
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Kesselheim AS, Hwang TJ. Breakthrough Medical Devices and the 21st Century Cures Act. Ann Intern Med. 2016;164:500–502. doi: 10.7326/M15-1906
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Published: Ann Intern Med. 2016;164(7):500-502.
Published at www.annals.org on 19 January 2016
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