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List of works by Janet Woodcock

A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma

scientific article

A Proactive Response to Prescription Opioid Abuse

scientific article

A difficult balance--pain management, drug safety, and the FDA.

scientific article published in November 2009

A regulatory perspective on in vitro diagnostics

scientific article published in August 2006

Abacavir induces loading of novel self-peptides into HLA-B*57: 01: an autoimmune model for HLA-associated drug hypersensitivity

scientific article

Accelerating Identification and Regulatory Approval of Investigational Cancer Drugs ⬇️

scientific article published on December 21, 2011

Addressing prescription opioid overdose: data support a comprehensive policy approach

scientific article

Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

scientific article published on 9 February 2016

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

scientific article

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

scientific article published on November 2010

An Improved Approach To Measuring Drug Innovation Finds Steady Rates Of First-In-Class Pharmaceuticals, 1987–2011 ⬇️

scientific article published on August 1, 2013

An audience with... Janet Woodcock discusses the role of the FDA in improving pharma productivity

scientific article published in November 2004

Assuring the benefits of modern medicine for all Americans

scientific article published on 01 September 2003

Audio Interview: An Update from Operation Warp Speed

scientific article published on 01 November 2020

Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives

scientific article published on July 2010

Biosimilars: The US Regulatory Framework

scientific article

Blood-based systems biology biomarkers for next-generation clinical trials in Alzheimer's disease

scholarly article by Harald Hampel et al published 1 January 2019 in Dialogues in Clinical Neuroscience

Bridging the Gap at Warp Speed - Delivering Options for Preventing and Treating Covid-19

scientific article published on 15 September 2020

Center for Drug Evaluation and Research Perspective on Quality in Clinical Trials

scientific article published on 16 April 2017

Clinical Trials Series

Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases

scientific article published on 01 November 2013

Combined Gabapentinoid and Opioid Use: The Consequences of Shifting Prescribing Trends

scientific article published on 21 August 2018

Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials

scientific article

Comparative effectiveness research and the regulation of drugs, biologics and devices

scientific article

Comparative effectiveness research: who will do the studies?

scientific article

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

scientific article

Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.

scientific article published on 23 February 2018

Contaminated heparin associated with adverse clinical events and activation of the contact system

scientific article

Defining safe use of anesthesia in children

scientific article published on 9 March 2011

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report

scientific article

Developing the Nation's Biosimilars Program ⬇️

scientific article published on 01 August 2011

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

scientific article published on 12 January 2011

Development of Novel Combination Therapies ⬇️

scientific article published on February 16, 2011

Drug Regulation in the Era of Individualized Therapies

scientific article published on 09 October 2019

Drug Trials Snapshots and Sexless Drug Labels-Reply

scientific article published in December 2017

Empowering microarrays in the regulatory setting

scientific article published on 01 September 2006

Expanded access to investigational drugs

scientific article published in April 2015

Expediting drug development for serious illness: Trade-offs between patient access and certainty

scientific article published on 01 June 2018

Expediting drug development--the FDA's new "breakthrough therapy" designation

scientific article published in November 2013

FDA Analysis of Atorvastatin Products Refutes Report of Methyl Ester Impurities

scientific article published on 01 September 2014

FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone

scientific article published on 01 May 2020

FDA introductory comments: clinical studies design and evaluation issues

scientific article published in January 2005

FDA pharmaceutical quality oversight

scientific article published on 29 May 2015

FDA regulations for drug development

scientific article published on 01 July 2010

FDA's Critical Path Initiative

scientific article published on 01 January 2007

FDA's Critical Path Initiative

FDG-PET lymphoma demonstration project invitational workshop

scientific article published on 01 March 2007

Facilitating Antibacterial Drug Development in a Time of Great Need

scientific article published on 01 August 2016

Grand challenges for psychiatric drug discovery: a perspective

scientific article

Immune-mediated pathology in Duchenne muscular dystrophy

scientific article published on August 2015

Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development

scientific article published on 27 October 2017

Improving Adverse Event Reporting for Compounded Drugs

scientific article published on 09 September 2019

Incentives for drug development—the curious case of colchicine

scientific article published on 01 October 2010

Integrated Drug Reviews at the US Food and Drug Administration

scientific article published on 27 July 2020

Interview with Janet Woodcock.

scientific article published in September 2010

Interview with Janet Woodcock: progress on the FDA's critical path initiative

scientific article published in December 2009

Janet Woodcock discusses the FDA and the drug development process. Interview by Christopher Watson

scientific article published in July 2004

Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic

scientific article published on 6 July 2017

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

scientific article published on 01 July 2017

Medical applications of microarray technologies: a regulatory science perspective

scientific article

Medication development in opioid addiction: Meaningful clinical end points

scientific article published in March 2018

Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data

scientific article published on 13 July 2017

New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact

scientific article published on 26 October 2020

New FDA Regulation to Improve Safety Reporting in Clinical Trials ⬇️

scientific article published on 08 June 2011

Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events

scientific article

Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

scientific article published on 01 May 2018

Patient-Centered Approach to Benefit-Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non-Small-Cell Lung Cancer

scientific article published on 01 August 2020

Paving the critical path of drug development: the CDER perspective

scientific article published on 01 November 2014

Pharmacogenetics and coumarin dosing--recalibrating expectations

scientific article published in December 2013

Pharmacogenetics--tailoring treatment for the outliers

scientific article published in February 2009

Pharmacogenetics: on the road to 'personalized medicine'

scientific article published on 01 November 2005

Precision pharmacology for Alzheimer's disease

scientific article published on 16 February 2018

Preventing prescription opioid abuse--reply

scientific article published in March 2015

Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview ⬇️

scientific article published on September 1, 2011

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

scientific article published on 03 August 2020

Real-World Evidence - What Is It and What Can It Tell Us?

scientific article

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

scientific article published on 01 September 2018

Reevaluating the accelerated approval process for oncology drugs

scientific article published on 03 April 2013

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

scientific article published on September 23, 2010

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

scientific article published on 22 December 2017

Regulatory watch: What drives differences in review times among CDER divisions?

scientific article published on 21 August 2015

Reliable Drug Quality: An Unresolved Problem

scientific article published on 01 May 2012

Research at the interface of industry, academia and regulatory science

scientific article published on 01 May 2010

Review of the Drug Trials Snapshots Program of the US Food and Drug Administration: Women in Cardiovascular Drug Trials

scientific article published on 13 March 2017

Risk management: issues for outcomes research

scientific article published on 01 July 2003

Role of Postmarketing Surveillance in Contemporary Medicine ⬇️

scientific article published on January 1, 2011

Safe & sound. Interview by Helena Gail Rubinstein.

scientific article published in March 2009

Scientific considerations in the review and approval of generic enoxaparin in the United States

scientific article published on March 2013

Stimulating the development of mechanism-based, individualized pain therapies

scientific article published in September 2007

The FDA and the Next Wave of Drug Abuse - Proactive Pharmacovigilance

scientific article published on 30 May 2018

The FDA and the safety of medical products

scientific article published in September 2005

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

scientific article

The FDA's Approach to the Prescription Opioid Problem

scientific article published on 23 March 2018

The FDA's assessment of follow-on protein products: a historical perspective

scientific article published on 01 June 2007

The Multiple Sclerosis Outcome Assessments Consortium: Bringing the Community Together to Shape the Future of Multiple Sclerosis Drug Development

scientific article published on 01 November 2013

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

scientific article published on 01 January 2012

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

scientific article published in June 2016

The clinical pharmacogeneticist: an emerging regulatory scientist at the US Food and Drug Administration

scientific article published on April 2010

The driving role of consortia on the critical path to innovative therapies

scientific article published on 01 November 2014

The human genome and translational research: how much evidence is enough?

scientific article

The progress and promise of molecular imaging probes in oncologic drug development

scientific article published in November 2005

The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology

scientific article published on January 2010

Toward Better-Quality Compounded Drugs - An Update from the FDA.

scientific article published in December 2017

Transforming Evidence Generation to Support Health and Health Care Decisions

scientific article published in December 2016

Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective

scientific article

Transporters in drug development: advancing on the Critical Path

scientific article published on 01 March 2010

Understanding pharmaceutical quality by design

scientific article published on 23 May 2014

Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma

scientific article published on 21 May 2019

Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma

scientific article published on 27 September 2019

Value Assessment in the Regulatory Context

scientific article published in February 2017

Withdrawal of Generic Budeprion for Nonbioequivalence ⬇️

scientific article published on 05 December 2012

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