Jonathan J. Darrow

Jonathan J. Darrow, A. Kesselheim, R. Beall, 2018, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents

Jonathan J. Darrow, A. Kesselheim, R. Beall, 2018, Applied Health Economics and Health Policy.

Will inter partes review speed US generic drug entry?

Jonathan J. Darrow, A. Kesselheim, R. Beall, 2017, Nature Biotechnology.

FDA Regulation and Approval of Medical Devices: 1976-2020.

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2021, JAMA.

Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel

Jonathan J. Darrow, A. Kesselheim, R. Redberg, 2022, Clinical pharmacology and therapeutics.

Changing FDA Approval Standards: Ethical Implications for Patient Consent

Jonathan J. Darrow, R. Redberg, S. Dhruva, 2021, Journal of General Internal Medicine.

Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations

Jonathan J. Darrow, J. van Rosmalen, D. Cucchi, 2022, Frontiers in Pharmacology.

Origins and Ownership of Remdesivir: Implications for Pricing

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2020, Journal of Law, Medicine & Ethics.

The FDA Breakthrough-Drug Designation - Four Years of Experience.

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2018, The New England journal of medicine.

Evidence Supporting the Value of Surgical Procedures: Can We Do Better?

Jonathan J. Darrow, W. Kasoff, C. Robertson, 2020, The American surgeon.

New FDA breakthrough-drug category--implications for patients.

Jonathan J. Darrow, Aaron S Kesselheim, Jerry Avorn, 2014, The New England journal of medicine.

Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020

Jonathan J. Darrow, Murray N. Ross, A. Kesselheim, 2022, JAMA network open.

Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities.

Jonathan J. Darrow, A. Kesselheim, M. Najafzadeh, 2020, The Lancet. Infectious diseases.

The Role of Public Funding

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2022 .

Government Pharmaceutical Development to Address High Prices: Challenges Ahead.

Jonathan J. Darrow, 2021, Therapeutic innovation & regulatory science.

Regulation of drugs for early Alzheimer's disease.

Jonathan J. Darrow, D. Light, 2013, The New England journal of medicine.

Repositioning Generic Drugs: Empirical Findings and Policy Implications

Jonathan J. Darrow, C. Crespo, M. Aboy, 2022, IIC - International Review of Intellectual Property and Competition Law.

Safeguarding evidence-based decision making in the FDA for COVID-19 vaccines

Jonathan J. Darrow, A. Angelis, 2021, Vaccine.

Few new drugs deserve expedited regulatory treatment.

Jonathan J. Darrow, 2020, Journal of managed care & specialty pharmacy.

Luxturna: FDA documents reveal the value of a costly gene therapy.

Jonathan J. Darrow, 2019, Drug discovery today.

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.

Jonathan J. Darrow, A. Kesselheim, B. Gyawali, 2018, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Practical, legal, and ethical issues in expanded access to investigational drugs.

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2015, The New England journal of medicine.

Approximating Future Generic Entry for New Drugs

Jonathan J. Darrow, A. Kesselheim, R. Beall, 2019, The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics.

FDA Approval and Regulation of Pharmaceuticals, 1983-2018.

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2020, JAMA.

Expanding Coverage of Oncology Drugs in an Aging, Upper-Middle-Income Country: Analyses of Public and Private Expenditures in Chile

Jonathan J. Darrow, Veronica Vargas, Marianela Castillo-Riquelme, 2019, Journal of global oncology.

Jonathan J. Darrow, A. Kesselheim, A. Sarpatwari, 2018, Clinical pharmacology and therapeutics.

Reconsidering the scope of US state laws allowing pharmacist substitution of generic drugs

Jonathan J. Darrow, A. Kesselheim, Jessica E Chong, 2020, BMJ.

Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VI

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2017, The New England journal of medicine.

Explaining the absence of surgical procedure regulation.

Jonathan J. Darrow, 2017, Cornell journal of law and public policy.

An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19.

Jonathan J. Darrow, M. Kulldorff, A. Kesselheim, 2020, Health affairs.

Adverse Employment Consequences Triggered by Criminal Convictions: Recent Cases Interpret State Statutes Prohibiting Discrimination

Jonathan J. Darrow, C. O'Brien, 2007 .

Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020

Jonathan J. Darrow, M. Versteegh, D. Cucchi, 2022, BMJ Open.

Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.

Jonathan J. Darrow, A. Kesselheim, M. Sinha, 2018, Chest.

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care

Jonathan J. Darrow, A. Kesselheim, R. Redberg, 2022, Journal of General Internal Medicine.

Two views of cancer medicines: Imagery versus evidence

Jonathan J. Darrow, 2022, Health marketing quarterly.

The Patentability of Enantiomers: Implications for the Pharmaceutical Industry

Jonathan J. Darrow, 2006 .

Efficacy and costs of spinal muscular atrophy drugs

Jonathan J. Darrow, A. Wagner, Monica Sharma, 2020, Science Translational Medicine.

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2022, JAMA internal medicine.

Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.

Jonathan J. Darrow, A. Kesselheim, D. Hine, 2018, Health affairs.

Pharmaceutical Efficacy: The Illusory Legal Standard

Jonathan J. Darrow, 2014 .

Understanding when real world data can be used to replicate a clinical trial: A cross‐sectional study of medications approved in 2011

Jonathan J. Darrow, A. Kesselheim, M. Fralick, 2020, Pharmacoepidemiology and drug safety.

Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era?

Jonathan J. Darrow, A. Kesselheim, 2015, Yale journal of health policy, law, and ethics.

Variation in Endpoints in FDA Medication Approvals

Jonathan J. Darrow, A. Kesselheim, Serena L Orr, 2023, Neurology.

Discovery and Development of Pregabalin (Lyrica)

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2021, Neurology.

Frequency of Approval and Marketing of Biosimilars With a Skinny Label and Associated Medicare Savings.

Jonathan J. Darrow, A. Kesselheim, A. Sarpatwari, 2022, JAMA internal medicine.

An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?

Jonathan J. Darrow, A. Kesselheim, T. Minssen, 2019, Nature Biotechnology.