United States Food and Drug Administration
-
Subject Areas on Research
-
"Real world" thoracic endografting: results with the Gore TAG device 2 years after U.S. FDA approval.
-
2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
-
21st Century Cures: A Step Forward for Patients With Heart Failure.
-
A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials.
-
A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?
-
A historical perspective on clinical trials innovation and leadership: where have the academics gone?
-
A new look at bladder neck obstruction by the food and drug administration regulators: guide lines for investigation of benign prostatic hypertrophy.
-
A perspective on the regulation of the evaluation of new antithrombotic drugs.
-
A pre-marketing ALT signal predicts post-marketing liver safety.
-
A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure.
-
A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia.
-
A survey of reports of quetiapine-associated hyperglycemia and diabetes mellitus.
-
A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements.
-
ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials.
-
Accountability in Patenting of Federally Funded Research
-
Adding pharmacogenetics information to drug labels: lessons learned.
-
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.
-
Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database.
-
Adverse drug reactions.
-
Adverse events in the use of HeartMate vented electric and Novacor left ventricular assist devices: comparing apples and oranges.
-
Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018.
-
All-Cause Mortality and Cardiovascular Outcomes With Non-Vitamin K Oral Anticoagulants Versus Warfarin in Patients With Heart Failure in the Food and Drug Administration Adverse Event Reporting System.
-
An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics.
-
Analysis of 408 Total Ankle Arthroplasty Adverse Events Reported to the US Food and Drug Administration From 2015 to 2018.
-
Analytical Similarity Assessment in Biosimilar Studies.
-
Antidepressant Regulatory Warnings, Prescription Patterns, Suicidality and Other Aggressive Behaviors in Major Depressive Disorder and Anxiety Disorders.
-
Antidepressants in pregnancy: a review of commonly prescribed medications.
-
Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.
-
Approaching Regulatory Approval of Cardiovascular Regenerative Therapy.
-
Assessing bioequivalence and drug interchangeability.
-
Assessing biosimilarity and interchangeability of biosimilar products.
-
Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.
-
Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.
-
Association between pathologic gambling and parkinsonian therapy as detected in the Food and Drug Administration Adverse Event database.
-
Atypical antipsychotic drugs and diabetes mellitus in the US Food and Drug Administration Adverse Event database: a systematic Bayesian signal detection analysis.
-
Atypical antipsychotics and pituitary tumors: a pharmacovigilance study.
-
Automated support for pharmacovigilance: a proposed system.
-
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.
-
Balancing the benefits and risks of inhaled long-acting beta-agonists--the influence of values.
-
Benefit the patient, manage the risk: a system goal.
-
Benefits, challenges and obstacles of adaptive clinical trial designs.
-
Biomarkers as Surrogate Endpoints: Ongoing Opportunities for Validation.
-
Biomarkers as drug development tools: discovery, validation, qualification and use.
-
Biomedical imaging symposium: visualizing the future of biology and medicine.
-
Biomedical innovation: a risky business at risk.
-
Bleeding After Musculoskeletal Surgery in Hospitals That Switched From Hydroxyethyl Starch to Albumin Following a Food and Drug Administration Warning.
-
Blinatumomab: A New Treatment for Adults With Relapsed Acute Lymphocytic Leukemia.
-
Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.
-
Building a drug development database: challenges in reliable data availability.
-
Building gold standard corpora for medical natural language processing tasks.
-
Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.
-
Cardiovascular drug development: is it dead or just hibernating?
-
Case reports of heart failure after therapy with a tumor necrosis factor antagonist.
-
Cell-based interventions for neurologic conditions: ethical challenges for early human trials.
-
Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.
-
Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
-
Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.
-
Clinical and Technical Considerations for Brain PET Imaging for Dementia.
-
Clinical strategies for selecting oral anticoagulants in patients with atrial fibrillation.
-
Clinical trials bureaucracy: unintended consequences of well-intentioned policy.
-
Clinical utility of the Food and Drug Administration Electrocardiogram Warehouse: a paradigm for the critical pathway initiative.
-
Clopidogrel-associated TTP: an update of pharmacovigilance efforts conducted by independent researchers, pharmaceutical suppliers, and the Food and Drug Administration.
-
Comments on the FDA draft guidance on biosimilar products.
-
Comparing Water Absorption of Food and Drug Administration-Approved Hyaluronic Acid Fillers.
-
Comparing data mining methods on the VAERS database.
-
Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).
-
Compliance with results reporting at ClinicalTrials.gov.
-
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.
-
Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment.
-
Congress, the FDA, and the fair development of new medications for children.
-
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.
-
Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration.
-
Contrast echocardiography: past, present, and...future?
-
Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay.
-
Cosmetics, Regulations, and the Public Health: Understanding the Safety of Medical and Other Products.
-
Coverage with evidence development for Medicare beneficiaries: challenges and next steps.
-
Criteria supporting the study of drugs in the newborn.
-
Curative vs targeted therapy for SCD: does it make more sense to address the root cause than target downstream events?
-
Current knowledge of the platelet glycoprotein IIb/IIIa receptor antagonists for the treatment of coronary artery disease.
-
Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.
-
Defining the balance of risk and benefit in the era of genomics and proteomics.
-
Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010-2020.
-
Deployment of convalescent plasma for the prevention and treatment of COVID-19.
-
Design and Analysis of Biosimilar Switching Studies.
-
Design considerations, architecture, and use of the Mini-Sentinel distributed data system.
-
Designing a Better Mousetrap: Reflections on the November 28, 2017, US Food and Drug Administration Meeting on Next-Generation "High-Sensitivity" Cardiac Troponin Assays to Diagnose Myocardial Infarction.
-
Developing drugs for developing countries.
-
Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.
-
Development, Validation, and Innovation in Ophthalmic Laser-Based Imaging: Report From a US Food and Drug Administration-Cosponsored Forum.
-
Device-related complications during renal cryoablation: insights from the Manufacturer and User Facility Device Experience (MAUDE) database.
-
Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015.
-
Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.
-
Drug Development. Are trade secrets delaying biosimilars?
-
Drug labeling and exposure in neonates.
-
Drug shortages in the United States: a critical evaluation of root causes and the need for action.
-
Drug-eluting stents "deliver heartburn": how do we spell relief going forward?
-
Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.
-
ECT failure rate among specific devices.
-
Economic return of clinical trials performed under the pediatric exclusivity program.
-
Editorial: Licensing and Use of New Therapies in MS: Where Are We Going?
-
Effects of Food and Drug Administration-approved medications for Alzheimer's disease on clinical progression.
-
Electroconvulsive therapy device classification: response to FDA advisory panel hearing and recommendations.
-
End points for clinical trials in acute heart failure syndromes.
-
Endovascular repair of descending thoracic aneurysms: results with "on-label" application in the post Food and Drug Administration approval era.
-
Enhancing measurement in health outcomes research supported by Agencies within the US Department of Health and Human Services.
-
Enhancing the technology of clinical trials and the trials model to evaluate newly developed, targeted antidepressants.
-
Erythropoiesis-stimulating agents in cancer.
-
Estimating drug shelf-life with random batches.
-
Ethical considerations in design of a study to evaluate a US Food and Drug Administration-approved indication: antivenom versus placebo for copperhead envenomation.
-
Ethical considerations regarding the implementation of new technologies and techniques in surgery.
-
Ethics and equipoise: rationale for a placebo-controlled study design of platelet glycoprotein IIb/IIIa inhibition in coronary intervention.
-
Ethics and regulatory complexities for pragmatic clinical trials.
-
Evaluating the role of blood collection centers in public health: a status report.
-
Evaluation of Flibanserin: Science and Advocacy at the FDA.
-
Evaluation of Representation of Women as Authors in Pivotal Trials Supporting US Food and Drug Administration Approval of Novel Cardiovascular Drugs.
-
Evaluation of diagnostic imaging technologies and therapeutics devices: better information for better decisions: proceedings of a multidisciplinary workshop.
-
Evidence strength in FDA premarket approval of cardiovascular devices.
-
Excess of Solid Cancers After Prasugrel: The Food and Drug Administration Outlook.
-
Exploring options for improving healthcare.
-
Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval.
-
Extending the Product Label for Ticagrelor: Looking Under the FDA Hood.
-
FDA approval of dapagliflozin for chronic kidney disease: a remarkable achievement?
-
FDA considers classification of ECT.
-
FDA in the 21st Century: Focus on Tobacco Policies and Heart Failure Prevention.
-
FDA jeopardizes the lives of lung transplant recipients and in the process severely increases the cost to develop new immunosuppression.
-
FDA review vouchers.
-
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.
-
Facial Filler Complications.
-
Factors affecting increasing radiation dose for mammography in North Carolina from 1997 through 2001: an analysis of Food and Drug Administration annual surveys.
-
Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.
-
Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.
-
First Food and Drug Administration-approved prospective trial of primary intracranial stenting for acute stroke: SARIS (stent-assisted recanalization in acute ischemic stroke).
-
Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2.
-
Flavorant-Solvent Reaction Products and Menthol in JUUL E-Cigarettes and Aerosol.
-
Food and Drug Administration: Cardiovascular and Renal Drugs Advisory Committee, 98th meeting, January 6th-7th, 2003.
-
Food and drug administration black box warning on the perioperative use of droperidol: a review of the cases.
-
Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) response to FDA (Docket no. 97N-0068). FAHCT Board of Directors.
-
Four health data networks illustrate the potential for a shared national multipurpose big-data network.
-
Front-of-package nutrition labeling--an abuse of trust by the food industry?
-
Functional co-primary measures for clinical trials in schizophrenia: results from the MATRICS Psychometric and Standardization Study.
-
Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications.
-
Gemtuzumab ozogamicin: is there room for salvage?
-
Gene therapies for hemophilia hit the mark in clinical trials.
-
Generating comparative evidence on new drugs and devices after approval.
-
Generic clopidogrel: time to substitute?
-
Genetically Modified Salmon and Full Impact Assessment
-
Genetics. FDA races in wrong direction.
-
Genomics-enabled drug repositioning and repurposing: insights from an IOM Roundtable activity.
-
Giving Patients a Meaningful Voice in United States Regulatory Decision Making: The Role for Health Preference Research.
-
HIV pre-exposure prophylaxis.
-
Haloperidol for postoperative nausea and vomiting: are we reinventing the wheel?
-
Harmonisation in study design and outcomes in paediatric antibiotic clinical trials: a systematic review.
-
Healthcare provider preferences for medical device labeling.
-
Heart Failure Collaboratory Statement on Clinical Trials in the Landscape of COVID-19.
-
Hereditary angioedema: current and emerging treatment options.
-
History and Justification of a National Blood Pressure Measurement Validated Device Listing.
-
How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.
-
How high the SPF?
-
Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.
-
Immunologic monitoring of cancer vaccine therapy: results of a workshop sponsored by the Society for Biological Therapy.
-
Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.
-
Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals.
-
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions.
-
Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.
-
Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials: A Call to Action From the Value in Healthcare Initiative's Partnering With Regulators Learning Collaborative.
-
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.
-
Improving Medication Adherence in Cardiometabolic Disease: Practical and Regulatory Implications.
-
Improving the Evidence Base for Treating Older Adults With Cancer: American Society of Clinical Oncology Statement.
-
Improving the assessment of heart toxicity for all new drugs through translational regulatory science.
-
In vitro bioequivalence testing.
-
In vitro exposure systems and dosimetry assessment tools for inhaled tobacco products: Workshop proceedings, conclusions and paths forward for in vitro model use.
-
Inclusion and diversity in clinical trials: Actionable steps to drive lasting change.
-
Incorporating patient-preference evidence into regulatory decision making.
-
Independent data monitoring committees: an update and overview.
-
Indications, labeling, and outcomes assessment for drugs aimed at improving functional status in older persons: a conversation between aging researchers and FDA regulators.
-
Individual- and Ad-Level Predictors of Perceptions of Serious and Actionable Risks in Direct-to-Consumer Prescription Drug TV Advertising.
-
Industry perspectives on ICH guidelines.
-
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.
-
Information Transparency in the Drug Approval Process.
-
Informed consent and investigational new drug abuses in the U.S. military.
-
Innovative design and analysis for rare disease drug development.
-
Integrating molecular technologies for red blood cell typing and compatibility testing into blood centers and transfusion services.
-
Issues in regulatory guidelines for data monitoring committees.
-
JACC: Heart Failure Series: FDA in the 21st Century: Focus on Nutrition and Heart Failure Prevention.
-
Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs.
-
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.
-
Letter by Mehran et al regarding article, "Bleeding academic research consortium consensus report: the food and drug administration perspective".
-
Leveraging Big Data in Pediatric Development Programs: Proceedings From the 2016 American College of Clinical Pharmacology Annual Meeting Symposium.
-
MASTERMIND: Bringing Microbial Diagnostics to the Clinic.
-
Machine Learning Uncovers Food- and Excipient-Drug Interactions.
-
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.
-
Making genuine progress against metastatic breast cancer.
-
Management of Blood Product Market Withdrawals - A Single Institution's Process and Experience.
-
Managing the risks of therapeutic products: proceedings of a workshop.
-
Mandatory diagnostic screening tests to individualize therapy: a curious paradox.
-
Marketing drugs too early in testing.
-
Medical Marijuana Laws Reduce Prescription Medication Use In Medicare Part D.
-
Medical chart validation of inpatient diagnosis codes for transfusion-related acute lung injury 2013-2015.
-
Medical device surveillance world-wide.
-
Mercury, vaccines, and autism: one controversy, three histories.
-
Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).
-
Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs.
-
Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.
-
Methodological issues in negative symptom trials.
-
Methodology of a reevaluation of cardiovascular outcomes in the RECORD trial: study design and conduct.
-
Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents.
-
Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs.
-
Molecular Imaging in the Head and Neck: Diagnosis and Therapy.
-
Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012.
-
New FDA breakthrough-drug category--implications for patients.
-
New drug application strategies for supraventricular arrhythmias.
-
New medical technologies in a cost containment environment: Implantable antitachyarrhythmia devices.
-
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.
-
No Shot: US Vaccine Prices And Shortages.
-
Noncollagen Dermal Fillers: A Summary of the Clinical Trials Used for Their FDA Approval.
-
Not Your Mother's FDA.
-
On safety margin for drug interchangeability.
-
On sample size requirement for analytical similarity assessment.
-
On stability designs in drug shelf-life estimation.
-
On statistical power for average bioequivalence testing under replicated crossover designs.
-
On the establishment of equivalence acceptance criterion in analytical similarity assessment.
-
On the estimation of total variability in assay validation.
-
On the independence of data monitoring committee in adaptive design clinical trials.
-
Oral antihypertensive trial design and analysis under the pediatric exclusivity provision.
-
Outcomes of Thoracic Endovascular Aortic Repair in Acute Type B Aortic Dissection: Results From the Valiant United States Investigational Device Exemption Study.
-
Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.
-
Package insert: view of a rural town practitioner.
-
Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
-
Pancreatitis associated with atypical antipsychotics: from the Food and Drug Administration's MedWatch surveillance system and published reports.
-
Patients, physicians, and clinical trials: the other side of the coins.
-
Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop.
-
Pediatric antihypertensive trial failures: analysis of end points and dose range.
-
Pediatric post-marketing safety systems in North America: assessment of the current status.
-
Peer-reviewed publication of clinical trials completed for pediatric exclusivity.
-
Peripheral T-cell lymphoma, NOS, and anaplastic large cell lymphoma.
-
Pharmacogenetics: Ethical Issues and Policy Options
-
Pharmacologic studies in vulnerable populations: Using the pediatric experience.
-
Pharmacovigilance and safety aspects of sevoflurane.
-
Pharmacovigilance in the 21st century: new systematic tools for an old problem.
-
Polymer hydrogels: Chaperoning vaccines.
-
Post-market surveillance to detect adverse events associated with Melody® valve implantation.
-
Postmarket evaluation of breakthrough technologies.
-
Potential Implications of Expanded US Food and Drug Administration Labeling for Sacubitril/Valsartan in the US.
-
Potential problems with increasing serving sizes on the Nutrition Facts label.
-
Practical CT dosimetry.
-
Practical Issues in Clinical Inspection Process.
-
Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial.
-
Precision diagnosis: a view of the clinical decision support systems (CDSS) landscape through the lens of critical care.
-
Preface. Bioequilavence measures.
-
Prescribing BiDil: is it black and white?
-
Prescribing rates and characteristics of recipients of tenofovir-containing regimens before and after market entry of tenofovir alafenamide.
-
Priorities for the Priority Review Voucher.
-
Pro: The Food and Drug Administration Black box warning on droperidol is not justified.
-
Proceedings of the 99th meeting of the Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee. May 29th and 30th, 2003.
-
Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016.
-
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.
-
Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.
-
Randomized Trial of Reduced-Nicotine Standards for Cigarettes.
-
Rapid assessment of cardiovascular risk among users of smoking cessation drugs within the US Food and Drug Administration's Mini-Sentinel program.
-
Rationing in urologic oncology: lessons from sipuleucel-T for advanced prostate cancer.
-
Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations.
-
Recombinant DNA Advisory Committee. Department of Health and Human Services. National Institutes of Health. Minutes of meeting. December 15-16, 1997.
-
Recommendations for the Use of Mechanical Circulatory Support: Ambulatory and Community Patient Care: A Scientific Statement From the American Heart Association.
-
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.
-
Regarding Plan B: science and politics cannot be separated.
-
Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.
-
Regulation Without Representation: Cardiac Device Patient Knowledge and Attitudes About the FDA Regulatory Process.
-
Regulation: The FDA is Overcautious on Consumer Genetics
-
Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015.
-
Regulatory Review of New Therapeutic Agents.
-
Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.
-
Report from the 94th Cardiovascular and Renal Drugs Advisory Committee Meeting, October 11, 2001.
-
Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience.
-
Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics.
-
Reproducibility probability in clinical trials.
-
Research design features and patient characteristics associated with the outcome of antidepressant clinical trials.
-
Response by McCord et al to Letter Regarding Article, "Designing a Better Mousetrap: Reflections on the November 28, 2017, US Food and Drug Administration Meeting on Next-Generation "High-Sensitivity" Cardiac Troponin Assays to Diagnose Myocardial Infarction".
-
Results of a reevaluation of cardiovascular outcomes in the RECORD trial.
-
Results of thoracic endovascular aortic repair 6 years after United States Food and Drug Administration approval.
-
Returns to R&D on new drug introductions in the 1980s.
-
Review of the accumulated PLATO documentation supports reliable and consistent superiority of ticagrelor over clopidogrel in patients with acute coronary syndrome: Commentary on: DiNicolantonio JJ, Tomek A, Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: serious concerns over the reliability of the PLATO trial, International Journal of Cardiology, 2013.
-
Role of the centers for education and research on therapeutics (CERTs) in pharmacovigilance and proper use of therapeutics.
-
Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations.
-
Safety and transparency of pediatric drug trials.
-
Safety monitoring of drugs receiving pediatric marketing exclusivity.
-
Safety of patients reason for FDA black box warning on droperidol.
-
Scientific considerations for assessing biosimilar products.
-
Selection bias, phase II trials, and the FDA accelerated approval process.
-
Senator Royal Copeland. The medical and political career of a homeopathic physician.
-
Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency.
-
Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?
-
Some thoughts on drug interchangeability.
-
Some thoughts on individual bioequivalence.
-
Some thoughts on the QR method for analytical similarity evaluation.
-
Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration.
-
Stability analysis for drugs with multiple active ingredients.
-
Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.
-
Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States.
-
Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States.
-
Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States: executive summary.
-
Statistical assessment of biosimilar products.
-
Statistical consideration of adaptive methods in clinical development.
-
Statistical considerations for rare diseases drug development.
-
Statistical evaluation of the scaled criterion for drug interchangeability.
-
Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report.
-
Suicidality as a possible side effect of antidepressant treatment.
-
Sulfites in medicines.
-
Summary of FDA antibody-mediated rejection workshop.
-
Summary of FDA workshop on ischemia reperfusion injury in kidney transplantation.
-
Surfactant Administration in Preterm Infants: Drug Development Opportunities.
-
Systematic survey of therapeutic trials for metastatic colorectal cancer: room for improvement in the critical pathway.
-
Telavancin.
-
Ten-Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs.
-
The 21st Century Cures Act.
-
The Cardiac Safety Research Consortium enters its second decade: An invitation to participate.
-
The Clinical Trials Transformation Initiative: Looking back, looking forward.
-
The Clinical Trials Transformation Initiative: Methodology supporting the mission.
-
The ClinicalTrials.gov results database--update and key issues.
-
The Commercial Market For Priority Review Vouchers.
-
The FDA Sentinel Initiative - An Evolving National Resource.
-
The FDA and ECT.
-
The FDA in the 21st Century: How Is the FDA Responding to the New World? A Focus on Cardiovascular Drug Development.
-
The FDA in the 21st Century: How Is the FDA Responding to the New World? A Focus on Heart Failure Devices.
-
The FDA-NIMH-MATRICS guidelines for clinical trial design of cognitive-enhancing drugs: what do we know 5 years later?
-
The Food and Drug Administration and pragmatic clinical trials of marketed medical products.
-
The Need for Pediatric Drug Development.
-
The Personalized Medicine Coalition: goals and strategies.
-
The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.
-
The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction.
-
The US Food and Drug Administration and the Future of Cardiovascular Medicine.
-
The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.
-
The academic research consortium governance charter.
-
The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment.
-
The bootstrap procedure in individual bioequivalence.
-
The coxib story: some lessons and more questions.
-
The effect of Medicaid formularies on the availability of new drugs.
-
The imperative of overcoming barriers to the conduct of large, simple trials.
-
The need for a national infrastructure to improve the rational use of therapeutics.
-
The new FDA labeling rule: impact on prescribing rheumatological medications during pregnancy.
-
The new Sentinel Network--improving the evidence of medical-product safety.
-
The nonapproved use of medications.
-
The opprobrium of Big Tobacco.
-
The role of machine learning in clinical research: transforming the future of evidence generation.
-
The safety of eating shellfish.
-
The science on front-of-package food labels.
-
The state and consequences of dermatology drug prices in the United States.
-
The trans-fat ban--food regulation and long-term health.
-
The unintended consequences of argument dilution in direct-to-consumer drug advertisements.
-
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.
-
The use of real-world data/evidence in regulatory submissions.
-
There should be a threshold dose for the FDA black-box warning on droperidol.
-
Transseptal Access-Gateway to Transcatheter Mitral Interventions.
-
Trends in Bare-Metal Stent Use in the United States in Patients Aged ≥65 Years (from the CathPCI Registry).
-
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.
-
Twenty-First Century Cures Act.
-
Two-phase shelf-life estimation.
-
U.S. Food and Drug Administration-Approved Poly (ADP-Ribose) Polymerase Inhibitor Maintenance Therapy for Recurrent Ovarian Cancer: A Cost-Effectiveness Analysis.
-
UHMS HBO₂ committee chair questions FDA on incorrect info.
-
US Food and Drug Administration Facilitated Pediatric Approval Programs: Application to Pediatric Neurological Disorders.
-
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
-
Understanding the sleep-wake cycle: sleep, insomnia, and the orexin system.
-
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.
-
Using registries to identify adverse events in rheumatic diseases.
-
Vasopressin receptor antagonists.
-
Vorapaxar and diplopia: Possible off-target PAR-receptor mismodulation.
-
Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".
-
What should work, may not.
-
What's next in the pipeline.
-
Why Dr. Robert Califf's Nomination for Commissioner of the Food and Drug Administration Is Good for Heart Failure Patients.
-
Why we work with the tobacco industry.
-
Will Precision Medicine Move Us beyond Race?
-
t⁴ workshop report. Nanotoxicology: "the end of the beginning" - signs on the roadmap to a strategy for assuring the safe application and use of nanomaterials.
-
US Tropical Disease Priority Review Vouchers: Lessons In Promoting Drug Development And Access.
-
Keywords of People
-
Curtis, Lesley H.,
Professor in Population Health Sciences,
Medicine, General Internal Medicine
-
O'Connor, Christopher Michael,
Richard Sean Stack, M.D. Distinguished Professor,
Medicine, Clinical Pharmacology
-
Sullivan, Daniel Carl,
Professor Emeritus of Radiology,
Radiology