Follow
Jonathan J. Darrow
Title
Cited by
Cited by
Year
FDA approval and regulation of pharmaceuticals, 1983-2018
JJ Darrow, J Avorn, AS Kesselheim
Jama 323 (2), 164-176, 2020
2822020
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
2592013
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
2112015
Luxturna: FDA documents reveal the value of a costly gene therapy
JJ Darrow
Drug discovery today 24 (4), 949-954, 2019
1832019
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
1352014
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
892017
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, ...
J Clin Oncol 36 (18), 1805-1812, 2018
862018
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
712006
The patentability of enantiomers: implications for the pharmaceutical industry
JJ Darrow
Stan. Tech. L. Rev., 2, 2007
672007
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
662019
FDA regulation and approval of medical devices: 1976-2020
JJ Darrow, J Avorn, AS Kesselheim
Jama 326 (5), 420-432, 2021
632021
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
572019
Drug development and FDA approval, 1938–2013
JJ Darrow, AS Kesselheim
New England Journal of Medicine 370 (26), e39, 2014
542014
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
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
502018
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
492021
Pharmaceutical efficacy: the illusory legal standard
JJ Darrow
Wash. & Lee L. Rev. 70, 2073, 2013
452013
The system can't perform the operation now. Try again later.
Articles 1–20