Product Surveillance, Postmarketing
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Subject Areas on Research
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A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.
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A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study).
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A pre-marketing ALT signal predicts post-marketing liver safety.
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Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database.
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Application of FDA adverse event report data to the surveillance of dietary botanical supplements.
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Assessment and management of cutaneous reactions with amifostine administration: findings of the ethyol (amifostine) cutaneous treatment advisory panel (ECTAP).
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Automated support for pharmacovigilance: a proposed system.
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Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks.
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Building a National Registry for Pelvic Organ Prolapse.
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Ceftaroline: clinical and microbiology experience with focus on methicillin-resistant Staphylococcus aureus after regulatory approval in the USA.
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Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.
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Clinical outcomes at 1 year following transcatheter aortic valve replacement.
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Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: one-year results from the XIENCE V USA study.
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Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study.
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Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.
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Clopidogrel-associated TTP: an update of pharmacovigilance efforts conducted by independent researchers, pharmaceutical suppliers, and the Food and Drug Administration.
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Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.
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Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration.
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Design considerations, architecture, and use of the Mini-Sentinel distributed data system.
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Device profile of the XVision-spine (XVS) augmented-reality surgical navigation system: overview of its safety and efficacy.
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Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015.
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Essentials of prescribing in the era of the Medicare Prescription Drug Improvement and Modernization Act.
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Ethical considerations in design of a study to evaluate a US Food and Drug Administration-approved indication: antivenom versus placebo for copperhead envenomation.
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FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.
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Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.
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Generating comparative evidence on new drugs and devices after approval.
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Global cardiovascular device innovation: Japan-USA synergies: Harmonization by Doing (HBD) program, a consortium of regulatory agencies, medical device industry, and academic institutions.
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Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.
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Improving pharmaceutical innovation by building a more comprehensive database on drug development and use.
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Index and follow-up costs of endovascular abdominal aortic aneurysm repair from the Endurant Stent Graft System Post Approval Study (ENGAGE PAS).
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Initial experience with teriparatide in the United States.
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Innovative Thinking on Endpoint Selection in Clinical Trials.
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Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model.
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Medical device surveillance world-wide.
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Meningococcal tetravalent conjugate vaccine.
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Midterm outcomes in patients undergoing endovascular repair of thoracic aortic aneurysms and penetrating atherosclerotic ulcers using the RelayPlus stent graft.
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Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study.
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National surveillance of herbal dietary supplement exposures: the poison control center experience.
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Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012.
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Newly Proposed Sepsis-Induced Coagulopathy Precedes International Society on Thrombosis and Haemostasis Overt-Disseminated Intravascular Coagulation and Predicts High Mortality.
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Outcomes following transcatheter aortic valve replacement in the United States.
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Part II: Sealing holes in the safety net.
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Pediatric cardiovascular safety: challenges in drug and device development and clinical application.
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Pediatric post-marketing safety systems in North America: assessment of the current status.
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Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.
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Pharmacovigilance and safety aspects of sevoflurane.
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Pipeline pharmacogenetics: a novel approach to integrating pharmaco-genetics into drug development.
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Population-based drug-related anaphylaxis in children and adolescents captured by South Carolina Emergency Room Hospital Discharge Database (SCERHDD) (2000-2002).
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Post-market surveillance to detect adverse events associated with Melody® valve implantation.
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Postlicensure study of varicella vaccine effectiveness in a day-care setting.
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Postmarket evaluation of breakthrough technologies.
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Postmarket surveillance and returned product analysis: success but not transparency.
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Predicting survival in patients receiving continuous flow left ventricular assist devices: the HeartMate II risk score.
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Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs.
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Purposeful learning with drug repurposing.
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Rapid assessment of cardiovascular risk among users of smoking cessation drugs within the US Food and Drug Administration's Mini-Sentinel program.
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Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) study.
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Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.
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Repairing the broken market for antibiotic innovation.
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Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics.
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Responding to the immunoglobulin shortage: a case study.
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Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).
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Risperidone-associated diabetes mellitus: a pharmacovigilance study.
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Spending on postapproval drug safety.
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Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States.
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Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States.
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Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States.
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Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States: executive summary.
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The FDA Sentinel Initiative - An Evolving National Resource.
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The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction.
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The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.
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The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment.
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The new Sentinel Network--improving the evidence of medical-product safety.
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The safety of tenofovir disoproxil fumarate for the treatment of HIV infection in adults: the first 4 years.
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US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
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Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration.
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Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities.
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What about celebrex?
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Keywords of People
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Badea, Cristian Tudorel,
Professor in Radiology,
Biomedical Engineering
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Clements III, Dennis Alfred,
Professor Emeritus of Pediatrics,
Pediatrics, General Pediatrics and Adolescent Health
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Curtis, Lesley H.,
Professor in Population Health Sciences,
Medicine, General Internal Medicine
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Ridley, David Blaine,
Professor of the Practice of Business Administration,
Duke Science & Society