关注
Jonathan J. Darrow
Jonathan J. Darrow
在 bwh.harvard.edu 的电子邮件经过验证
标题
引用次数
引用次数
年份
FDA approval and regulation of pharmaceuticals, 1983-2018
JJ Darrow, J Avorn, AS Kesselheim
Jama 323 (2), 164-176, 2020
2942020
Institutional corruption of pharmaceuticals and the myth of safe and effective drugs
DW Light, J Lexchin, JJ Darrow
Journal of Law, Medicine & Ethics 41 (3), 590-600, 2013
2642013
Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
AS Kesselheim, B Wang, JM Franklin, JJ Darrow
Bmj 351, 2015
2142015
Luxturna: FDA documents reveal the value of a costly gene therapy
JJ Darrow
Drug discovery today 24 (4), 949-954, 2019
1882019
Practical, legal, and ethical issues in expanded access to investigational drugs
JJ Darrow, A Sarpatwari, J Avorn, AS Kesselheim
New England Journal of Medicine 372 (3), 279-286, 2015
1612015
New FDA breakthrough-drug category—implications for patients
JJ Darrow, J Avorn, AS Kesselheim
New England Journal of Medicine 370 (13), 1252-1258, 2014
1372014
Hatch-Waxman turns 30: do we need a re-designed approach for the modern era
AS Kesselheim, JJ Darrow
Yale J. Health Pol'y L. & Ethics 15, 293, 2015
882015
Efficacy, safety, and regulatory approval of Food and Drug Administration–designated breakthrough and nonbreakthrough cancer medicines
TJ Hwang, JM Franklin, CT Chen, JC Lauffenburger, B Gyawali, ...
Journal of Clinical Oncology 36 (18), 1805-1812, 2018
862018
The FDA’s expedited programs and clinical development times for novel therapeutics, 2012-2016
TJ Hwang, JJ Darrow, AS Kesselheim
Jama 318 (21), 2137-2138, 2017
862017
Neglected Dimension of Patent Law's PHOSITA Standard
JJ Darrow
Harv. JL & Tech. 23, 227, 2009
812009
Who Owns a Decedents E-Mails: Inheritable Probate Assets or Property of the Network?
JJ Darrow, GR Ferrera
NYUJ Legis. & Pub. Pol'y 10, 281, 2006
722006
Designing development programs for non-traditional antibacterial agents
JH Rex, H Fernandez Lynch, IG Cohen, JJ Darrow, K Outterson
Nature communications 10 (1), 3416, 2019
712019
FDA regulation and approval of medical devices: 1976-2020
JJ Darrow, J Avorn, AS Kesselheim
Jama 326 (5), 420-432, 2021
682021
The patentability of enantiomers: implications for the pharmaceutical industry
JJ Darrow
Stan. Tech. L. Rev., 2, 2007
682007
The US biosimilar market: stunted growth and possible reforms
A Sarpatwari, R Barenie, G Curfman, JJ Darrow, AS Kesselheim
Clinical Pharmacology & Therapeutics 105 (1), 92-100, 2019
592019
FDA designations for therapeutics and their impact on drug development and regulatory review outcomes
AS Kesselheim, JJ Darrow
Clinical Pharmacology & Therapeutics 97 (1), 29-36, 2015
532015
An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19: Analysis reviews the Food and Drug Administration's critical vaccine approval role …
AS Kesselheim, JJ Darrow, M Kulldorff, BL Brown, M Mitra-Majumdar, ...
Health Affairs 40 (1), 25-32, 2021
522021
The FDA breakthrough-drug designation—four years of experience
JJ Darrow, J Avorn, AS Kesselheim
New England Journal of Medicine 378 (15), 1444-1453, 2018
522018
Drug development and FDA approval, 1938–2013
JJ Darrow, AS Kesselheim
New England Journal of Medicine 370 (26), e39, 2014
522014
Pharmaceutical efficacy: the illusory legal standard
JJ Darrow
Wash. & Lee L. Rev. 70, 2073, 2013
452013
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