United States Food and Drug Administration
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Subject Areas on Research
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"Real world" thoracic endografting: results with the Gore TAG device 2 years after U.S. FDA approval.
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21st Century Cures: A Step Forward for Patients With Heart Failure.
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A comparison of FDA and EMA drug approval: implications for drug development and cost of care.
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A historical perspective on clinical trials innovation and leadership: where have the academics gone?
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A new look at bladder neck obstruction by the food and drug administration regulators: guide lines for investigation of benign prostatic hypertrophy.
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A perspective on the regulation of the evaluation of new antithrombotic drugs
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A pre-marketing ALT signal predicts post-marketing liver safety.
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A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure.
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A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia.
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A survey of reports of quetiapine-associated hyperglycemia and diabetes mellitus.
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ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials.
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Accountability in Patenting of Federally Funded Research
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Achieving meaningful device surveillance: from reaction to proaction.
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Adding pharmacogenetics information to drug labels: lessons learned.
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Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.
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Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database.
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Adverse drug reactions.
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Analytical Similarity Assessment in Biosimilar Studies.
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Antidepressant Regulatory Warnings, Prescription Patterns, Suicidality and Other Aggressive Behaviors in Major Depressive Disorder and Anxiety Disorders.
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Antidepressant and QT interval prolongation, how should we look at this issue? Focus on citalopram.
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Antidepressants in pregnancy: a review of commonly prescribed medications.
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Assessing bioequivalence and drug interchangeability.
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Assessing biosimilarity and interchangeability of biosimilar products.
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Association Between Contemporary Trends in Inferior Vena Cava Filter Placement and the 2010 US Food and Drug Administration Advisory.
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Association between pathologic gambling and parkinsonian therapy as detected in the Food and Drug Administration Adverse Event database.
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Atypical antipsychotic drugs and diabetes mellitus in the US Food and Drug Administration Adverse Event database: a systematic Bayesian signal detection analysis.
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Atypical antipsychotics and pituitary tumors: a pharmacovigilance study.
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Automated support for pharmacovigilance: a proposed system.
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Awareness of the Food and Drug Administration's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings.
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Balancing the benefits and risks of inhaled long-acting beta-agonists--the influence of values.
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Benefit the patient, manage the risk: a system goal.
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Biomedical imaging symposium: visualizing the future of biology and medicine.
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Biomedical innovation: a risky business at risk.
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Blinatumomab: A New Treatment for Adults With Relapsed Acute Lymphocytic Leukemia.
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Building a drug development database: challenges in reliable data availability.
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Building gold standard corpora for medical natural language processing tasks.
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Buprenorphine treatment: factors and first-hand experiences for providers to consider.
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Can the Institute of Medicine review the FDA?
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Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.
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Cardiovascular drug development: is it dead or just hibernating?
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Case reports of heart failure after therapy with a tumor necrosis factor antagonist.
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Cell-based interventions for neurologic conditions: ethical challenges for early human trials.
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Clinical strategies for selecting oral anticoagulants in patients with atrial fibrillation.
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Clinical trials bureaucracy: unintended consequences of well-intentioned policy.
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Clinical utility of the Food and Drug Administration Electrocardiogram Warehouse: a paradigm for the critical pathway initiative.
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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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Compliance with results reporting at ClinicalTrials.gov.
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Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis.
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Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment.
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Congress, the FDA, and the fair development of new medications for children.
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Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer.
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Contrast echocardiography: past, present, and...future?
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Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay.
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Cosmetics, Regulations, and the Public Health: Understanding the Safety of Medical and Other Products.
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Coverage with evidence development for Medicare beneficiaries: challenges and next steps.
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Criteria supporting the study of drugs in the newborn.
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Current knowledge of the platelet glycoprotein IIb/IIIa receptor antagonists for the treatment of coronary artery disease.
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Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.
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Defining the balance of risk and benefit in the era of genomics and proteomics.
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Design considerations, architecture, and use of the Mini-Sentinel distributed data system.
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Designing drug trials: considerations for pregnant women.
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Developing drugs for developing countries.
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Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.
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Drug Development. Are trade secrets delaying biosimilars?
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Drug labeling and exposure in neonates.
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Drug shortages in the United States: a critical evaluation of root causes and the need for action.
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Drug-eluting stents "deliver heartburn": how do we spell relief going forward?
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ECT failure rate among specific devices.
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Economic implications of potential changes to regulatory and reimbursement policies for medical devices.
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Economic return of clinical trials performed under the pediatric exclusivity program.
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Effects of Food and Drug Administration-approved medications for Alzheimer's disease on clinical progression.
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Electroconvulsive therapy device classification: response to FDA advisory panel hearing and recommendations.
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End points for clinical trials in acute heart failure syndromes.
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Endovascular repair of descending thoracic aneurysms: results with "on-label" application in the post Food and Drug Administration approval era.
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Enhancing measurement in health outcomes research supported by Agencies within the US Department of Health and Human Services.
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Erythropoiesis-stimulating agents in cancer.
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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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Ethical considerations regarding the implementation of new technologies and techniques in surgery.
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Ethics and equipoise: rationale for a placebo-controlled study design of platelet glycoprotein IIb/IIIa inhibition in coronary intervention.
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Ethics and regulatory complexities for pragmatic clinical trials.
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Evaluation of Flibanserin: Science and Advocacy at the FDA.
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Evaluation of diagnostic imaging technologies and therapeutics devices: better information for better decisions: proceedings of a multidisciplinary workshop.
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Evidence strength in FDA premarket approval of cardiovascular devices.
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Excess of Solid Cancers After Prasugrel: The Food and Drug Administration Outlook.
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Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines.
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Exploring options for improving healthcare.
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Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval.
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FDA considers classification of ECT.
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FDA in the 21st Century: Focus on Tobacco Policies and Heart Failure Prevention.
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Facial Filler Complications.
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Food and Drug Administration: Cardiovascular and Renal Drugs Advisory Committee, 98th meeting, January 6th-7th, 2003.
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Food and drug administration black box warning on the perioperative use of droperidol: a review of the cases.
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Food safety. Genetically modified salmon and full impact assessment.
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Four health data networks illustrate the potential for a shared national multipurpose big-data network.
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Functional co-primary measures for clinical trials in schizophrenia: results from the MATRICS Psychometric and Standardization Study.
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Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications.
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Generic clopidogrel: time to substitute?
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Genetics. FDA races in wrong direction.
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Genomics-enabled drug repositioning and repurposing: insights from an IOM Roundtable activity.
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Giving Patients a Meaningful Voice in United States Regulatory Decision Making: The Role for Health Preference Research.
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HIV pre-exposure prophylaxis.
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Haloperidol for postoperative nausea and vomiting: are we reinventing the wheel?
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Harmonisation in study design and outcomes in paediatric antibiotic clinical trials: a systematic review.
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Healthcare provider preferences for medical device labeling.
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How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.
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Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.
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Immunologic monitoring of cancer vaccine therapy: results of a workshop sponsored by the Society for Biological Therapy.
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Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.
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Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.
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Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.
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Improving Medication Adherence in Cardiometabolic Disease: Practical and Regulatory Implications.
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Improving the Evidence Base for Treating Older Adults With Cancer: American Society of Clinical Oncology Statement.
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Improving the assessment of heart toxicity for all new drugs through translational regulatory science.
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In vitro bioequivalence testing.
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Incorporating patient-preference evidence into regulatory decision making.
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Independent data monitoring committees: an update and overview.
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Indications, labeling, and outcomes assessment for drugs aimed at improving functional status in older persons: a conversation between aging researchers and FDA regulators.
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Industry perspectives on ICH guidelines.
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Influence of Kidney Function Estimation Methods on Eligibility for Edoxaban Population Impact of the US Food and Drug Administration's Approach for Its Product Labeling.
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Informed consent and investigational new drug abuses in the U.S. military.
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Issues in regulatory guidelines for data monitoring committees.
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JACC: Heart Failure Series: FDA in the 21st Century: Focus on Nutrition and Heart Failure Prevention.
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Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs.
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Letter by Mehran et al regarding article, "Bleeding academic research consortium consensus report: the food and drug administration perspective".
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MASTERMIND: Bringing Microbial Diagnostics to the Clinic.
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Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the manufacturer and user facility device experience (MAUDE) database.
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Making genuine progress against metastatic breast cancer.
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Managing the risks of therapeutic products: proceedings of a workshop.
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Mandatory diagnostic screening tests to individualize therapy: a curious paradox.
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Marketing drugs too early in testing.
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Medical Marijuana Laws Reduce Prescription Medication Use In Medicare Part D.
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Medical device surveillance world-wide.
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Mercury, vaccines, and autism: one controversy, three histories.
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Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.
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Methodological issues in negative symptom trials.
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Methodology of a reevaluation of cardiovascular outcomes in the RECORD trial: study design and conduct.
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Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012.
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Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012.
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New FDA breakthrough-drug category--implications for patients.
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New drug application strategies for supraventricular arrhythmias.
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New rules for clinical trials of patients with acute bacterial skin and skin-structure infections: do not let the perfect be the enemy of the good.
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No Shot: US Vaccine Prices And Shortages.
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Not Your Mother's FDA.
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On safety margin for drug interchangeability.
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On statistical power for average bioequivalence testing under replicated crossover designs.
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On the establishment of equivalence acceptance criterion in analytical similarity assessment.
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Operation of a radiopharmacy for a clinical trial.
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Oral antihypertensive trial design and analysis under the pediatric exclusivity provision.
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Outcomes of Thoracic Endovascular Aortic Repair in Acute Type B Aortic Dissection: Results From the Valiant United States Investigational Device Exemption Study.
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Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.
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Package insert: view of a rural town practitioner.
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Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
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Pancreatitis associated with atypical antipsychotics: from the Food and Drug Administration's MedWatch surveillance system and published reports.
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Patients, physicians, and clinical trials: the other side of the coins.
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Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop.
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Pediatric antihypertensive trial failures: analysis of end points and dose range.
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Pediatric post-marketing safety systems in North America: assessment of the current status.
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Peer-reviewed publication of clinical trials completed for pediatric exclusivity.
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Peripheral T-cell lymphoma, NOS, and anaplastic large cell lymphoma.
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Pharmacologic studies in vulnerable populations: Using the pediatric experience.
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Pharmacovigilance in the 21st century: new systematic tools for an old problem.
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Polymer hydrogels: Chaperoning vaccines.
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Post-market surveillance to detect adverse events associated with Melody® valve implantation.
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Postmarket evaluation of breakthrough technologies.
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Potential problems with increasing serving sizes on the Nutrition Facts label.
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Practical CT dosimetry.
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Precision diagnosis: a view of the clinical decision support systems (CDSS) landscape through the lens of critical care.
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Prescribing BiDil: is it black and white?
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Priorities for the Priority Review Voucher.
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Pro: The Food and Drug Administration Black box warning on droperidol is not justified.
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Proceedings of the 99th meeting of the Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee. May 29th and 30th, 2003.
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Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016.
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Proposed 'grant-and-access' program with price caps could stimulate development of drugs for very rare diseases.
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Public health. A case study of personalized medicine.
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Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.
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Randomized Trial of Reduced-Nicotine Standards for Cigarettes.
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Rationing in urologic oncology: lessons from sipuleucel-T for advanced prostate cancer.
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Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations.
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Recommendations for clinical trials of off-label drugs used to treat advanced-stage cancer.
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Recommendations for the Use of Mechanical Circulatory Support: Ambulatory and Community Patient Care: A Scientific Statement From the American Heart Association.
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Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial.
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Regarding Plan B: science and politics cannot be separated.
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Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.
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Regulating manufacturer-affiliated communication in the information age.
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Regulation: The FDA is Overcautious on Consumer Genetics
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Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.
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Report from the 94th Cardiovascular and Renal Drugs Advisory Committee Meeting, October 11, 2001.
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Reproducibility probability in clinical trials.
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Research design features and patient characteristics associated with the outcome of antidepressant clinical trials.
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Results of a reevaluation of cardiovascular outcomes in the RECORD trial.
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Results of thoracic endovascular aortic repair 6 years after United States Food and Drug Administration approval.
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Returns to R&D on new drug introductions in the 1980s.
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Role of the centers for education and research on therapeutics (CERTs) in pharmacovigilance and proper use of therapeutics.
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Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations.
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Safety and transparency of pediatric drug trials.
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Safety monitoring of drugs receiving pediatric marketing exclusivity.
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Selection bias, phase II trials, and the FDA accelerated approval process.
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Senator Royal Copeland. The medical and political career of a homeopathic physician.
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Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?
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Some thoughts on drug interchangeability.
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Specialty Pharmaceuticals for Hyperlipidemia--Impact on Insurance Premiums.
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Statistical consideration of adaptive methods in clinical development.
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Statistical evaluation of the scaled criterion for drug interchangeability.
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Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report.
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Suicidality as a possible side effect of antidepressant treatment.
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Sulfites in medicines.
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Summary of FDA antibody-mediated rejection workshop.
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Summary of FDA workshop on ischemia reperfusion injury in kidney transplantation.
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Systematic survey of therapeutic trials for metastatic colorectal cancer: room for improvement in the critical pathway.
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Telavancin.
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The 21st Century Cures Act.
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The Cardiac Safety Research Consortium enters its second decade: An invitation to participate.
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The ClinicalTrials.gov results database--update and key issues.
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The Commercial Market For Priority Review Vouchers.
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The FDA and ECT.
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The FDA in the 21st Century: How Is the FDA Responding to the New World? A Focus on Cardiovascular Drug Development.
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The FDA in the 21st Century: How Is the FDA Responding to the New World? A Focus on Heart Failure Devices.
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The FDA-NIMH-MATRICS guidelines for clinical trial design of cognitive-enhancing drugs: what do we know 5 years later?
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The Food and Drug Administration and pragmatic clinical trials of marketed medical products.
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The Need for Pediatric Drug Development.
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The Personalized Medicine Coalition: goals and strategies.
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The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.
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The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.
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The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction.
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The US Food and Drug Administration and the Future of Cardiovascular Medicine.
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The Use of Systemic and Topical Fluoroquinolones.
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The academic research consortium governance charter.
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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 bootstrap procedure in individual bioequivalence.
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The coxib story: some lessons and more questions.
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The effect of Medicaid formularies on the availability of new drugs.
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The imperative of overcoming barriers to the conduct of large, simple trials.
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The need for a national infrastructure to improve the rational use of therapeutics.
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The new FDA labeling rule: impact on prescribing rheumatological medications during pregnancy.
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The nonapproved use of medications.
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The opprobrium of Big Tobacco.
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The safety of eating shellfish.
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The science on front-of-package food labels.
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The state and consequences of dermatology drug prices in the United States.
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The trans-fat ban--food regulation and long-term health.
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The use of droperidol before and after the Food and Drug Administration black box warning: a survey of the members of the Society of Ambulatory Anesthesia.
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Trends in Bare-Metal Stent Use in the United States in Patients Aged ≥65 Years (from the CathPCI Registry).
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Troponin measurements during drug development--considerations for monitoring and management of potential cardiotoxicity: an educational collaboration among the Cardiac Safety Research Consortium, the Duke Clinical Research Institute, and the US Food and Drug Administration.
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Two-phase shelf-life estimation.
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Understanding the sleep-wake cycle: sleep, insomnia, and the orexin system.
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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 registries to identify adverse events in rheumatic diseases.
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Vasopressin receptor antagonists.
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Vorapaxar and diplopia: Possible off-target PAR-receptor mismodulation.
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Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".
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What should work, may not.
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What's next in the pipeline.
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Why Dr. Robert Califf's Nomination for Commissioner of the Food and Drug Administration Is Good for Heart Failure Patients.
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Will Precision Medicine Move Us beyond Race?
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Keywords of People
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Curtis, Lesley H.,
Professor in Population Health Sciences,
Medicine, General Internal Medicine
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O'Connor, Christopher Michael,
Richard Sean Stack, M.D. / Guidant Foundation Professor of Cardiology,
Medicine, Clinical Pharmacology
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Sullivan, Daniel Carl,
Professor Emeritus of Radiology,
Radiology