Janet Woodcock
#37,592
Most Influential Person Now
American physician
Janet Woodcock's AcademicInfluence.com Rankings
Janet Woodcockphilosophy Degrees
Philosophy
#8323
World Rank
#11678
Historical Rank
#1690
USA Rank
Logic
#7107
World Rank
#8751
Historical Rank
#1027
USA Rank
Download Badge
Philosophy
Janet Woodcock's Degrees
- Masters Medicine Northwestern University
Why Is Janet Woodcock Influential?
(Suggest an Edit or Addition)According to Wikipedia, Janet Woodcock is an American physician serving as Principal Deputy Commissioner of Food and Drugs, having previously served as Acting Commissioner of the U.S. Food and Drug Administration . She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research from 1994 to 2004 and 2007 to 2021.
Janet Woodcock's Published Works
Number of citations in a given year to any of this author's works
Total number of citations to an author for the works they published in a given year. This highlights publication of the most important work(s) by the author
Published Works
- Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework (2001) (5642)
- Real-World Evidence - What Is It and What Can It Tell Us? (2016) (1197)
- Understanding Pharmaceutical Quality by Design (2014) (746)
- Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives (2010) (616)
- Contaminated heparin associated with adverse clinical events and activation of the contact system. (2008) (576)
- Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. (2017) (561)
- Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events (2008) (559)
- Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production (2015) (558)
- Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. American Society of Clinical Oncology. (1996) (417)
- The FDA critical path initiative and its influence on new drug development. (2008) (397)
- Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership (2010) (338)
- Developing the Sentinel System--a national resource for evidence development. (2011) (326)
- Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration (2009) (308)
- Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness. (2018) (241)
- The safety of newly approved medicines: do recent market removals mean there is a problem? (1999) (234)
- Medical applications of microarray technologies: a regulatory science perspective (2002) (230)
- The Progress and Promise of Molecular Imaging Probes in Oncologic Drug Development (2005) (228)
- Development of novel combination therapies. (2011) (221)
- A Proactive Response to Prescription Opioid Abuse. (2016) (221)
- Defining safe use of anesthesia in children. (2011) (207)
- Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective (2004) (205)
- Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs. (2018) (185)
- Challenges in the Design and Interpretation of Noninferiority Trials (2017) (185)
- Immune-mediated pathology in Duchenne muscular dystrophy (2015) (181)
- Developing the nation's biosimilars program. (2011) (181)
- The Prospects for “Personalized Medicine” in Drug Development and Drug Therapy (2007) (177)
- Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization (2015) (167)
- Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. (2010) (158)
- Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages (2012) (154)
- Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data. (2017) (150)
- The FDA's assessment of follow-on protein products: a historical perspective (2007) (143)
- A difficult balance--pain management, drug safety, and the FDA. (2009) (138)
- Adaptive platform trials: definition, design, conduct and reporting considerations (2019) (132)
- Food and Drug Administration Center for Drug Evaluation and Research (1996) (125)
- Expediting drug development--the FDA's new "breakthrough therapy" designation. (2013) (114)
- The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety (2012) (112)
- An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011. (2013) (111)
- Transforming Evidence Generation to Support Health and Health Care Decisions. (2016) (111)
- Stimulating the development of mechanism-based, individualized pain therapies (2007) (106)
- Pharmacogenomic-guided drug development: regulatory perspective (2002) (98)
- Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report. (2010) (98)
- Pharmacogenetics--tailoring treatment for the outliers. (2009) (97)
- The US regulatory and pharmacopeia response to the global heparin contamination crisis (2016) (86)
- Assessing the Clinical Utility of Diagnostics Used in Drug Therapy (2010) (85)
- Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials. (1991) (83)
- Accelerated Access to Innovative Medicines for Patients in Need (2014) (83)
- The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology. (2010) (77)
- Precision pharmacology for Alzheimer's disease. (2018) (74)
- Novel bioequivalence approach for narrow therapeutic index drugs (2015) (68)
- Accelerating identification and regulatory approval of investigational cancer drugs. (2011) (66)
- Scientific considerations in the review and approval of generic enoxaparin in the United States (2013) (65)
- Pharmacogenetics and coumarin dosing--recalibrating expectations. (2013) (64)
- Pharmacological Mechanism‐Based Drug Safety Assessment and Prediction (2011) (60)
- The FDA and the Next Wave of Drug Abuse - Proactive Pharmacovigilance. (2018) (60)
- Trends in COVID-19 therapeutic clinical trials (2021) (54)
- Evidence vs. Access: Can Twenty‐First‐Century Drug Regulation Refine the Tradeoffs? (2012) (54)
- Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality. (2016) (51)
- Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making (1999) (48)
- Precompetitive Research: A New Prescription for Drug Development? (2010) (47)
- Transporters in drug development: advancing on the Critical Path (2010) (46)
- Empowering microarrays in the regulatory setting (2006) (43)
- Withdrawal of generic budeprion for nonbioequivalence. (2012) (43)
- New FDA regulation to improve safety reporting in clinical trials. (2011) (42)
- Role of postmarketing surveillance in contemporary medicine. (2011) (42)
- Research at the interface of industry, academia and regulatory science (2010) (41)
- Addressing prescription opioid overdose: data support a comprehensive policy approach. (2014) (37)
- Biosimilars: The US Regulatory Framework. (2017) (37)
- FDA pharmaceutical quality oversight. (2015) (35)
- Catalyzing the critical path initiative: FDA's progress in drug development activities (2015) (34)
- Clinical Pharmacology and the Catalysis of Regulatory Science: Opportunities for the Advancement of Drug Development and Evaluation (2013) (33)
- Chutes and Ladders on the Critical Path:Comparative Effectiveness, Product Value, and the Use of Biomarkers in Drug Development (2009) (33)
- FDA introductory comments: clinical studies design and evaluation issues (2005) (30)
- Medication development in opioid addiction: Meaningful clinical end points (2018) (29)
- FDG-PET lymphoma demonstration project invitational workshop. (2007) (27)
- How many deaths are due to medical errors? (2000) (26)
- Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview. (2011) (26)
- Reevaluating the Accelerated Approval Process for Oncology Drugs (2013) (25)
- Drug Regulation in the Era of Individualized Therapies. (2019) (25)
- Advancing Product Quality: a Summary of the Second FDA/PQRI Conference (2016) (23)
- FDA's Critical Path Initiative. (2007) (22)
- Integrating Research into Community Practice - Toward Increased Diversity in Clinical Trials. (2021) (21)
- Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development. (2017) (21)
- The Multiple Sclerosis Outcome Assessments Consortium (2013) (20)
- Blood-based systems biology biomarkers for next-generation clinical trials in Alzheimer’s disease (2019) (19)
- Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic. (2017) (16)
- Clinical Trials Series (2016) (16)
- Brain Aβ load association and sexual dimorphism of plasma BACE1 concentrations in cognitively normal individuals at risk for AD (2019) (16)
- The PCAST Report on Pharmaceutical Innovation: Implications for the FDA (2013) (15)
- Comparative effectiveness research: who will do the studies? (2010) (15)
- Bridging the Gap at Warp Speed - Delivering Options for Preventing and Treating Covid-19. (2020) (15)
- Coalition Against Major Diseases (2013) (15)
- Considerations for Developing Targeted Therapies in Low‐Frequency Molecular Subsets of a Disease (2018) (14)
- Reliable Drug Quality: An Unresolved Problem (2012) (14)
- A Benefit–Risk Analysis Approach to Capture Regulatory Decision‐Making: Multiple Myeloma (2018) (14)
- The human genome and translational research: how much evidence is enough? (2008) (13)
- Paving the critical path of drug development: the CDER perspective (2014) (13)
- Pharmacogenetics: on the road to 'personalized medicine'. (2005) (12)
- Review of the Drug Trials Snapshots Program of the US Food and Drug Administration: Women in Cardiovascular Drug Trials (2017) (12)
- FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone. (2020) (11)
- 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 (2021) (11)
- The driving role of consortia on the critical path to innovative therapies (2014) (11)
- “Precision” drug development? (2016) (11)
- Expediting drug development for serious illness: Trade-offs between patient access and certainty (2018) (11)
- A Benefit–Risk Analysis Approach to Capture Regulatory Decision‐Making: Non‐Small Cell Lung Cancer (2016) (11)
- Drug Development in Serious Diseases: The New “Breakthrough Therapy” Designation (2014) (11)
- The Future of Orphan Drug Development (2012) (11)
- Combined Gabapentinoid and Opioid Use: The Consequences of Shifting Prescribing Trends (2018) (10)
- Association of plasma YKL-40 with brain amyloid-β levels, memory performance, and sex in subjective memory complainers (2020) (10)
- FDA's Critical Path Initiative. (2007) (10)
- Therapeutic Neutralizing Monoclonal Antibodies: Report of a Summit sponsored by Operation Warp Speed and the National Institutes of Health (2020) (9)
- The FDA's Approach to the Prescription Opioid Problem (2018) (9)
- Molecular Medicine: How, What, and When? (2007) (9)
- COVID-19 Vaccination-Becoming Part of the New Normal. (2022) (8)
- The clinical pharmacogeneticist: An emerging regulatory scientist at the US Food and Drug Administration (2010) (8)
- An FDA perspective on the drug development process. (1997) (8)
- FDA regulations for drug development. (2010) (7)
- Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019. (2021) (7)
- Comparative effectiveness research and the regulation of drugs, biologics and devices. (2013) (7)
- A Model for Accelerating Identification and Regulatory Approval of Effective Investigational Agents (2012) (7)
- Progress and opportunities for women in clinical trials: A look at recent data and initiatives from the U.S. FDA. (2021) (7)
- Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma (2019) (6)
- Innovation in Development, Regulatory Review, and Use of Clinical Advances: A Vital Direction for Health and Health Care (2016) (6)
- Incentives for drug development—the curious case of colchicine. (2010) (6)
- The NIH-led research response to COVID-19 (2023) (6)
- Toward Better-Quality Compounded Drugs - An Update from the FDA. (2017) (6)
- FDA senior management perspectives (2005) (5)
- A Shift in the Regulatory Approach (1998) (5)
- Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease (2017) (5)
- Improving Adverse Event Reporting for Compounded Drugs. (2019) (5)
- Benefits of Streamlined Point-of-Care Trial Designs: Lessons Learned From the UK RECOVERY Study. (2022) (5)
- Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma (2020) (4)
- A regulatory perspective on in vitro diagnostics (2006) (4)
- Value Assessment in the Regulatory Context. (2017) (4)
- Janet Woodcock discusses the role of the FDA in improving pharma productivity (2004) (4)
- Janet Woodcock discusses the FDA and the drug development process. Interview by Christopher Watson. (2004) (4)
- Grand Challenges for Psychiatric Drug Discovery: A Perspective (2008) (4)
- AlzheimerâÂÂs and ParkinsonâÂÂs Diseases Face Common Challenges inTherapeutic Development: Role of the Precompetitive Consortium,Coalition Against Major Diseases (2015) (4)
- Facilitating Antibacterial Drug Development in a Time of Great Need. (2016) (3)
- FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals (2012) (3)
- Department of Health and Human Services Food and Drug Administration International Conference on Harmonisation; Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data; Availability (3)
- Integrated Drug Reviews at the US Food and Drug Administration. (2020) (3)
- Bioinformatics Modernization and the Critical Path to Improved Benefit-Risk Assessment of Drugs (2008) (3)
- Author Correction: Adaptive platform trials: definition, design, conduct and reporting considerations (2019) (3)
- Chapter 18 – Physiological and Laboratory Markers of Drug Effect (2012) (3)
- MAQC and the era of genomic medicine (2021) (3)
- Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US (2020) (3)
- Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women. (2021) (2)
- FDA Analysis of Atorvastatin Products Refutes Report of Methyl Ester Impurities (2014) (2)
- From CGMPs to the Critical Path FDA Focuses on Innovation , Quality , and Continuous Improvement — Inside and Out (2004) (2)
- Building Biobetters: The Regulatory Landscape (2015) (2)
- Interview with Janet Woodcock: progress on the FDA's critical path initiative. (2009) (2)
- Developing a Clinical Trials Infrastructure in the United States (2012) (2)
- FDA Policyon Pharmacogenomic Data in Drug Development (2005) (1)
- Regulatory Perspectives on Pharmacogenomics (2005) (1)
- Expanded access to investigational drugs. (2015) (1)
- Reducing Sodium Intake in the US: Healthier Lives, Healthier Future. (2021) (1)
- Risk management: issues for outcomes research. (2003) (1)
- Patient-Centered Approach to Benefit-Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non-Small-Cell Lung Cancer. (2020) (1)
- Riposte: FDA response to ‘Yin, yang and the biopharmaceutical industry’ (2003) (1)
- Regulatory Issues for Genomic Technologies (2013) (1)
- Buyers Up a Congress Watch * Critical Mass * Global Trade Watch * Health Research Group (0)
- Chapter 26: Biotechnology, Nanotechnology, and Pharmacogenomics (2020) (0)
- Directions for the Future (1999) (0)
- Audio Interview: An Update from Operation Warp Speed. (2020) (0)
- Febrile Neutropenia: Good Results with Tigecycline Combos BY KURT SAMSON (2014) (0)
- Innovations for the Drug Development Pathway: What Is Needed Now (2006) (0)
- AMERICAN COLLEGE OF CLINICAL PHARMACOLOGY 33RD ANNUAL MEETING PRELIMINARY PROGRAM OCTOBER 3–5, 2004, WIGWAM RESORT, PHOENIX, ARIZONA (2004) (0)
- Drug Trials Snapshots and Sexless Drug Labels-Reply. (2017) (0)
- Preventing prescription opioid abuse--reply. (2015) (0)
- Center for Drug Evaluation and Research Perspective on Quality in Clinical Trials (2017) (0)
- Drug Development for Neurodegenerative Diseases Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating (2014) (0)
- Speakers and Panelists (1999) (0)
- Regulatory watch: What drives differences in review times among CDER divisions? (2015) (0)
- From the Literature (2002) (0)
- FDA Has Grown More Familiar With Personalized Medicine (2013) (0)
- Racial and Ethnic Representation of Participants in US Clinical Trials of New Drugs and Biologics-Reply. (2022) (0)
- New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact (2020) (0)
- Presubmission and Submission (1999) (0)
- CHAPTER 35 – Federal Regulation of Genomic Medicine (2009) (0)
- Janet Woodcock (2007) (0)
- FDA Regulatory Review (1999) (0)
- Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production (2015) (0)
- ROUNDTABLE ON RESEARCH AND DEVELOPMENT OF DRUGS, BIOLOGICS, AND MEDICAL DEVICES (1999) (0)
- Safe & sound. Interview by Helena Gail Rubinstein. (2009) (0)
- Assuring the benefits of modern medicine for all Americans. (2003) (0)
- FDA MARCH 22-23, 2012 HEARING ON RX TO OTC SWITCH - Selfcare Journal (2015) (0)
- FDA perspective on risk management programs. (2001) (0)
- Regulatory Perspectives on Biomarker Development (2012) (0)
- Understanding Pharmaceutical Quality by Design Citation (2014) (0)
- Federal Regulation of Genomic Medicine (2010) (0)
- Summary of Issues (1999) (0)
- Interview with Janet Woodcock. (2010) (0)
- Local, State, and FDA Dignitaries Attending (2006) (0)
- 2011 AAPS Annual Meeting and Exposition KEYNOTE SPEAKER (2011) (0)
- The FDA and the safety of medical products. (2005) (0)
- Hello, goodbye (2008) (0)
- 10 influential people to watch in biomedical policy (2008) (0)
- Commentary: The reintroduction of Lotronex for diarrhea-predominant irritable bowel syndrome (2003) (0)
- Recent FDA Approvals Demonstrate Promise of Precision Medicine (2017) (0)
- Advancing Product Quality: a Summary of the Second FDA/PQRI Conference (2016) (0)
- AMERICAN COLLEGE OF CLINICAL PHARMACOLOGY 33RD ANNUAL MEETING PRELIMINARY PROGRAM OCTOBER 3–5, 2004, WIGWAM RESORT, PHOENIX, ARIZONA (2004) (0)
- CCR Perspectives in Drug Approval Reevaluating theAcceleratedApprovalProcess forOncology Drugs (2013) (0)
This paper list is powered by the following services:
Other Resources About Janet Woodcock
What Schools Are Affiliated With Janet Woodcock?
Janet Woodcock is affiliated with the following schools:
