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One or more keywords matched the following items that are connected to Kesselheim, Aaron
Item TypeName
Academic Article Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
Academic Article Generic immunosuppressants in hematopoietic cell transplantation.
Academic Article Improving antibiotic markets for long-term sustainability.
Academic Article Fighting antibiotic resistance: marrying new financial incentives to meeting public health goals.
Academic Article Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.
Academic Article Market-based licensing for HPV vaccines in developing countries.
Academic Article Gene patenting--is the pendulum swinging back?
Academic Article Priority review vouchers: an inefficient and dangerous way to promote neglected-disease drug development.
Academic Article Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis.
Academic Article Expert review of drug patent applications: improving health in the developing world.
Academic Article State generic substitution laws can lower drug outlays under Medicaid.
Academic Article Biotechnology products and university-based science
Academic Article Questions about the 10 x '20 Initiative.
Academic Article The backlash against bioequivalence and the interchangeability of brand-name and generic drugs.
Academic Article University-based science and biotechnology research: defining the boundaries of intellectual property
Concept Antitubercular Agents
Concept Evidence-Based Medicine
Concept Antiparasitic Agents
Concept Anti-Arrhythmia Agents
Concept Antirheumatic Agents
Concept Cardiovascular Agents
Concept Anticholesteremic Agents
Concept Base Sequence
Concept Antineoplastic Agents
Concept Hypolipidemic Agents
Concept Immunosuppressive Agents
Concept Bronchodilator Agents
Concept Dermatologic Agents
Concept Anti-Bacterial Agents
Concept Anti-Infective Agents
Concept Anti-HIV Agents
Concept Antidepressive Agents
Concept Antihypertensive Agents
Concept Central Nervous System Agents
Concept Safety-Based Drug Withdrawals
Concept Antipsychotic Agents
Concept Antiprotozoal Agents
Concept Hypoglycemic Agents
Academic Article Gene patenting--the Supreme Court finally speaks.
Academic Article Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009.
Academic Article What is the public's right to access medical discoveries based on federally funded research?
Academic Article Assessing the chiral switch: approval and use of single-enantiomer drugs, 2001 to 2011.
Academic Article Target small firms for antibiotic innovation.
Academic Article Restrictions on pharmaceutical detailing reduced off-label prescribing of antidepressants and antipsychotics in children.
Academic Article Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case-control studies.
Academic Article Association of marketing interactions with medical trainees' knowledge about evidence-based prescribing: results from a national survey.
Academic Article A matter of trust: patient barriers to primary medication adherence.
Academic Article Chemotherapy parity laws: a remedy for high drug costs?
Academic Article High-cost generic drugs--implications for patients and policymakers.
Academic Article Innovative research methods for studying treatments for rare diseases: methodological review.
Academic Article Burden of changes in generic pill appearance.
Academic Article Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population.
Academic Article Availability and utilization of cardiovascular fixed-dose combination drugs in the United States.
Academic Article High-cost generic drugs--implications for patients and policymakers.
Academic Article Evidence, errors, and ethics.
Academic Article Paying for innovation: reimbursement incentives for antibiotics.
Academic Article The Safety of Prescription Drugs.
Academic Article Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014.
Academic Article Experience With the Priority Review Voucher Program for Drug Development.
Academic Article Evolution of insulin patents and market exclusivities in the USA.
Academic Article Brief Report: Utilization of the First Biosimilar Infliximab Since Its Approval in South Korea.
Academic Article Two decades of new drug development for central nervous system disorders.
Academic Article Insulin patents and market exclusivities: unresolved issues--Authors' reply.
Academic Article Inaccurate Reporting of Insulin Reimbursement-Reply.
Academic Article An Uninformative Truth: The Logic of Amarin's Off-Label Promotion.
Academic Article Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis.
Academic Article Navigating the Dermatological Drug Cost Curve.
Academic Article The FDA, Juno Therapeutics, and the ethical imperative of transparency.
Grant Off-label prescribing: Comparative evidence, regulation, and utilization
Grant Assessing Clinical Equivalence for Generic Drugs Approved By Innovative Methods
Academic Article Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015.
Academic Article Generic Drug Approvals Since the 1984 Hatch-Waxman Act.
Academic Article Comparative effectiveness and safety of thalidomide and lenalidomide in patients with multiple myeloma in the United States of America: A population-based cohort study.
Academic Article Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals.
Academic Article The Fight Against Multidrug-Resistant Bacteria.
Academic Article Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations.
Academic Article Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development.
Academic Article Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer.
Academic Article Coverage of Magnetic Resonance Imaging for Patients With Cardiac Devices: Improving the Coverage With Evidence Development Program.
Academic Article Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors.
Academic Article Journey of Generic Imatinib: A Case Study in Oncology Drug Pricing.
Academic Article Challenges in the Development of Novel Cardiovascular Therapies.
Academic Article Value-Based Pricing and State Reform of Prescription Drug Costs.
Academic Article Outcomes-Based Pharmaceutical Contracts: An Answer to High U.S. Drug Spending?
Academic Article Trends in Pricing and Generic Competition Within the Oral Antibiotic Drug Market in the United States.
Academic Article Leveraging Novel and Existing Pathways to Approve New Therapeutics to Treat Serious Drug-Resistant Infections.
Academic Article Evidence Required for Drugs Granted Accelerated Approval-Reply.
Academic Article Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits?
Academic Article The FDA Breakthrough-Drug Designation - Four Years of Experience.
Academic Article Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.
Academic Article Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.
Academic Article Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015.
Academic Article Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System.
Academic Article US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?
Academic Article Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers.
Academic Article Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis.
Academic Article Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis.
Academic Article A Systematic Review and Meta-Analysis of Bevacizumab in First-Line Metastatic Breast Cancer: Lessons for Research and Regulatory Enterprises.
Academic Article Desmopressin and the risk of hyponatremia: A population-based cohort study.
Academic Article US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.
Academic Article Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.
Academic Article Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study.
Academic Article Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities.
Academic Article Generating comparative evidence on new drugs and devices before approval.
Academic Article New drug approvals in oncology.
Academic Article Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany.
Academic Article Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs.
Academic Article US Spending Associated With Transition From Daily to 3-Times-Weekly Glatiramer Acetate.
Academic Article Producing and using timely comparative evidence on drugs: lessons from clinical trials for covid-19.
Academic Article Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program.
Academic Article Social, cultural and economic aspects of antimicrobial resistance.
Academic Article Non-warfarin oral anticoagulant copayments and adherence in atrial fibrillation: A population-based cohort study.
Academic Article FDA approval standards for anticancer agents - lessons from two recent approvals in breast cancer.
Academic Article Diabetes Drugs: List Price Increases Were Not Always Reflected In Net Price; Impact Of Brand Competition Unclear.
Academic Article Cost to Medicare of Delayed Adalimumab Biosimilar Availability.
Academic Article Pursuing Value-Based Prices for Drugs: A Comprehensive Comparison of State Prescription Drug-Pricing Boards.
Academic Article Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study.
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Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.