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Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both

The New England journal of medicine, 2017-07, Vol.377 (1), p.62-70

2017

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A Difficult Balance — Pain Management, Drug Safety, and the FDA

The New England journal of medicine, 2009-11, Vol.361 (22), p.2105-2107

Woodcock, Janet

2009

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Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness

JAMA : the journal of the American Medical Association, 2018-09, Vol.320 (9), p.867

2018

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The FDA critical path initiative and its influence on new drug development

Annual review of medicine, 2008-01, Vol.59 (1), p.1-12

2008

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Understanding Pharmaceutical Quality by Design

The AAPS journal, 2014-07, Vol.16 (4), p.771-783

2014

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Defining Safe Use of Anesthesia in Children

The New England journal of medicine, 2011-04, Vol.364 (15), p.1387-1390

2011

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Immune-mediated pathology in Duchenne muscular dystrophy

Science translational medicine, 2015-08, Vol.7 (299), p.299rv4

2015

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Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

Journal of pharmaceutical innovation, 2015-09, Vol.10 (3), p.191-199

2015

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Developing the Sentinel System--a national resource for evidence development

The New England journal of medicine, 2011-02, Vol.364 (6), p.498-499

2011

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Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration

The New England journal of medicine, 2010-10, Vol.363 (16), p.1489-1491

2010

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Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation

The New England journal of medicine, 2013-11, Vol.369 (20), p.1877-1880

2013

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Biosimilars: The US Regulatory Framework

Annual review of medicine, 2017-01, Vol.68 (1), p.243-254

2017

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Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership

Annals of internal medicine, 2010-11, Vol.153 (9), p.600

2010

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The US regulatory and pharmacopeia response to the global heparin contamination crisis

Nature biotechnology, 2016-06, Vol.34 (6), p.625-630

2016

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Update on and Future Directions for Use of Anti-SARS-CoV-2 Antibodies: National Institutes of Health Summit on Treatment and Prevention of COVID-19

Annals of internal medicine, 2022-01, Vol.175 (1), p.119-126

2022

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Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality

International journal of pharmaceutics, 2016-12, Vol.515 (1-2), p.390-402

2016

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Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective

Nature reviews. Drug discovery, 2004-09, Vol.3 (9), p.763-769

2004

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Drug Regulation in the Era of Individualized Therapies

The New England journal of medicine, 2019-10, Vol.381 (17), p.1678-1680

2019

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Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration

The Annals of pharmacotherapy, 2009-10, Vol.43 (10), p.1583-1597

2009

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Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease

Nature reviews. Drug discovery, 2018-02, Vol.17 (2), p.79-80

2018

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The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

Pharmacoepidemiology and drug safety, 2012-01, Vol.21 (S1), p.9-11

2012

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Trends in COVID-19 therapeutic clinical trials

Nature reviews. Drug discovery, 2021-04, Vol.20 (4), p.254-255

2021

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The Role of the U.S. Food and Drug Administration Review Process: Clinical Trial Endpoints in Oncology

The oncologist (Dayton, Ohio), 2010-01, Vol.15 (S1), p.13-18

2010

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Transporters in drug development: advancing on the Critical Path

Nature reviews. Drug discovery, 2010-03, Vol.9 (3), p.175-176

2010

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Value Assessment in the Regulatory Context

Value in health, 2017-02, Vol.20 (2), p.296-298

2017

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Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both

A Difficult Balance — Pain Management, Drug Safety, and the FDA

Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness

The FDA critical path initiative and its influence on new drug development

Understanding Pharmaceutical Quality by Design

Defining Safe Use of Anesthesia in Children

Immune-mediated pathology in Duchenne muscular dystrophy

Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

Developing the Sentinel System--a national resource for evidence development

Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration

Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation

Biosimilars: The US Regulatory Framework

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership

The US regulatory and pharmacopeia response to the global heparin contamination crisis

Update on and Future Directions for Use of Anti-SARS-CoV-2 Antibodies: National Institutes of Health Summit on Treatment and Prevention of COVID-19

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality

Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective

Drug Regulation in the Era of Individualized Therapies

Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration

Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease

The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

Trends in COVID-19 therapeutic clinical trials

The Role of the U.S. Food and Drug Administration Review Process: Clinical Trial Endpoints in Oncology

Transporters in drug development: advancing on the Critical Path

Value Assessment in the Regulatory Context

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