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List of works by Jonathan J Darrow

A Method for Approximating Future Entry of Generic Drugs

scientific article published on 11 June 2018

A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?

scientific article published on January 2015

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

scientific article published on 19 November 2020

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

scientific article published on 01 January 2019

Approximating Future Generic Entry for New Drugs

scientific article published on 01 March 2019

Changing FDA Approval Standards: Ethical Implications for Patient Consent

scientific article published on 08 April 2021

Commentary: Expedited Regulatory Review of Low-Value Drugs

scientific article published on 01 May 2020

Comparing Onset of Biosimilar Versus Generic Competition in the United States

scientific article published on 04 July 2020

Designing development programs for non-traditional antibacterial agents

scientific article published on 31 July 2019

Drug Shortages and the Defense Production Act

scientific article published on 01 October 2020

Drug development and FDA approval, 1938-2013.

scientific article

Efficacy and costs of spinal muscular atrophy drugs

scientific article published on 01 November 2020

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

scientific article published on 24 April 2018

Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs.

scientific article published on October 2014

Expanded access to investigational drugs

scientific article

FDA Approval and Regulation of Pharmaceuticals, 1983-2018

scientific article published on 01 January 2020

FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.

scientific article

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

scientific article published on January 2015

Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working?

scientific article published on 28 January 2020

New FDA breakthrough-drug category--implications for patients

scientific article published on 01 July 2014

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

scientific article

Origins and Ownership of Remdesivir: Implications for Pricing

scientific article published on 01 September 2020

Patent term restoration for top-selling drugs in the United States

scientific article published on 25 July 2018

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

scientific article published in January 2018

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

scientific article

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

scientific article published on 01 May 2018

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

scientific article published on 23 June 2020

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

scientific article published on 02 June 2020

Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI.

scientific article published in December 2017

The FDA Breakthrough-Drug Designation - Four Years of Experience

scientific article published in April 2018

The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.

scientific article published in December 2017

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

scientific article published on 01 February 2019

The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health

scientific article published on 20 December 2017

The US Biosimilar Market: Stunted Growth and Possible Reforms

scientific article published on 28 December 2018

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

scientific article

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

scientific article published on 14 August 2020

Will inter partes review speed US generic drug entry?

scientific article published in December 2017

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