FDA approval and regulation of pharmaceuticals, 1983-2018 JJ Darrow, J Avorn, AS Kesselheim Jama 323 (2), 164-176, 2020 | 294 | 2020 |
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 | 264 | 2013 |
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 | 214 | 2015 |
Luxturna: FDA documents reveal the value of a costly gene therapy JJ Darrow Drug discovery today 24 (4), 949-954, 2019 | 188 | 2019 |
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 | 161 | 2015 |
New FDA breakthrough-drug category—implications for patients JJ Darrow, J Avorn, AS Kesselheim New England Journal of Medicine 370 (13), 1252-1258, 2014 | 137 | 2014 |
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 | 88 | 2015 |
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 | 86 | 2018 |
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 | 86 | 2017 |
Neglected Dimension of Patent Law's PHOSITA Standard JJ Darrow Harv. JL & Tech. 23, 227, 2009 | 81 | 2009 |
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 | 72 | 2006 |
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 | 71 | 2019 |
FDA regulation and approval of medical devices: 1976-2020 JJ Darrow, J Avorn, AS Kesselheim Jama 326 (5), 420-432, 2021 | 68 | 2021 |
The patentability of enantiomers: implications for the pharmaceutical industry JJ Darrow Stan. Tech. L. Rev., 2, 2007 | 68 | 2007 |
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 | 59 | 2019 |
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 | 53 | 2015 |
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 | 52 | 2021 |
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 | 52 | 2018 |
Drug development and FDA approval, 1938–2013 JJ Darrow, AS Kesselheim New England Journal of Medicine 370 (26), e39, 2014 | 52 | 2014 |
Pharmaceutical efficacy: the illusory legal standard JJ Darrow Wash. & Lee L. Rev. 70, 2073, 2013 | 45 | 2013 |