Lista de obras -

A Method for Approximating Future Entry of Generic Drugs

artículo científico publicado en 2018

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

artículo científico publicado en 2015

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

artículo científico publicado en 2020

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

artículo científico publicado en 2019

Approximating Future Generic Entry for New Drugs

artículo científico publicado en 2019

Changing FDA Approval Standards: Ethical Implications for Patient Consent

artículo científico publicado en 2021

Commentary: Expedited Regulatory Review of Low-Value Drugs

artículo científico publicado en 2020

Comparing Onset of Biosimilar Versus Generic Competition in the United States

artículo científico publicado en 2020

Designing development programs for non-traditional antibacterial agents

artículo científico publicado en 2019

Drug Shortages and the Defense Production Act

artículo científico publicado en 2020

Drug development and FDA approval, 1938-2013.

artículo científico publicado en 2014

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

artículo científico publicado en 2018

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

artículo científico

Expanded access to investigational drugs

artículo científico publicado en 2015

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.

artículo científico publicado en 2014

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

artículo científico

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

artículo científico publicado en 2014

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

artículo científico publicado en 2014

Origins and Ownership of Remdesivir: Implications for Pricing

artículo científico publicado en 2020

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

artículo científico publicado en 2018

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

artículo científico publicado en 2018

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

artículo científico publicado en 2015

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

artículo científico publicado en 2018

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

artículo científico publicado en 2020

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

artículo científico publicado en 2020

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

artículo científico publicado en 2017

The FDA Breakthrough-Drug Designation - Four Years of Experience

artículo científico publicado en 2018

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

artículo científico publicado en 2017

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

artículo científico publicado en 2019

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

artículo científico publicado en 2017

The US Biosimilar Market: Stunted Growth and Possible Reforms

artículo científico publicado en 2018

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

artículo científico publicado en 2015

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?

artículo científico publicado en 2017

Lista de obras de

A Method for Approximating Future Entry of Generic Drugs

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

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

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

Approximating Future Generic Entry for New Drugs

Changing FDA Approval Standards: Ethical Implications for Patient Consent

Commentary: Expedited Regulatory Review of Low-Value Drugs

Comparing Onset of Biosimilar Versus Generic Competition in the United States

Designing development programs for non-traditional antibacterial agents

Drug Shortages and the Defense Production Act

Drug development and FDA approval, 1938-2013.

Efficacy and costs of spinal muscular atrophy drugs

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

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

Expanded access to investigational drugs

FDA Approval and Regulation of Pharmaceuticals, 1983-2018

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

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

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

New FDA breakthrough-drug category--implications for patients

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

Origins and Ownership of Remdesivir: Implications for Pricing

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

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

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

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

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

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

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

The FDA Breakthrough-Drug Designation - Four Years of Experience

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

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

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

The US Biosimilar Market: Stunted Growth and Possible Reforms

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

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

Will inter partes review speed US generic drug entry?