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List of works by Aaron S Kesselheim

"Pay for delay" settlements of disputes over pharmaceutical patents

scientific article published on 14 September 2011

'Government Patent Use': A Legal Approach To Reducing Drug Spending

scientific article

A Comparison of Response Patterns for Progression-Free Survival and Overall Survival Following Treatment for Cancer With PD-1 Inhibitors: A Meta-analysis of Correlation and Differences in Effect Sizes

scientific article published on 01 June 2018

A Global Intellectual Property Waiver is Still Needed to Address the Inequities of COVID-19 and Future Pandemic Preparedness

scientific article published in 2022

A Method for Approximating Future Entry of Generic Drugs

scientific article published on 11 June 2018

A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?

scientific article published on January 2015

A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications

scientific article published on 10 January 2019

A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway

scientific article published on 01 October 2018

A Systematic Review and Meta-Analysis of Bevacizumab in First-Line Metastatic Breast Cancer: Lessons for Research and Regulatory Enterprises

scientific article published on 25 October 2019

A cross-national comparison of 17 countries' insulin glargine drug labels

scientific article published on 24 September 2014

A hemorrhage of off-label use.

scientific article

A matter of trust: patient barriers to primary medication adherence

scientific article published on 16 May 2014

A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways

scientific article published on 01 November 2020

A randomized study of how physicians interpret research funding disclosures

scientific article published on September 2012

Accelerated Approval and Expensive Drugs - A Challenging Combination

scientific article published in May 2017

Accelerating innovation in rapid diagnostics and targeted antibacterials

scientific article

Accounting for US public funding in drug development: how can we better balance access, affordability, and innovation?

scientific article published on 08 October 2020

Active Surveillance of Follow-on Biologics: A Prescription for Uptake.

scientific article published on 12 November 2016

Adalimumab Pricing and Market Exclusivity for Biologics ⬇️

scientific article published on 01 December 2010

Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov

scientific article published on 10 February 2018

Affordability and Price Increases of New Cancer Drugs in Clinical Guidelines, 2007-2016

scientific article published on 01 April 2018

Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

scientific article published on 19 March 2018

An Empirical Review of Major Legislation Affecting Drug Development: Past Experiences, Effects, and Unintended Consequences ⬇️

scientific article published on September 1, 2011

An Incomplete Prescription

scientific article published in The Journal of the American Medical Association

An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles

scientific article published on 01 September 2020

An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19

scientific article published on 19 November 2020

An Uninformative Truth: The Logic of Amarin's Off-Label Promotion

scientific article

An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?

scientific article published on 01 January 2019

Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs

scientific article published on 01 March 2019

Anti-VEGF therapy in ophthalmology: a qualitative analysis of transformative drug development.

scientific article published on 7 May 2016

Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety

scientific article published on 01 June 2018

Application and impact of run-in studies

scientific article published on 15 February 2018

Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU

scientific article published on 10 October 2019

Applying Academic Detailing and Process Change to Promote Choosing Wisely

scientific article published on 01 February 2017

Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009.

scientific article published on January 2013

Approval of high-risk medical devices in the US: implications for clinical cardiology

scientific article

Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy.

scientific article

Approximating Future Generic Entry for New Drugs

scientific article published on 01 March 2019

Are risk evaluation and mitigation strategies associated with less off-label use of medications? The case of immune thrombocytopenia.

scientific article

Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis

scientific article published on 02 August 2019

Assessing the chiral switch: approval and use of single-enantiomer drugs, 2001 to 2011.

scientific article published in March 2014

Assessment of US pathway for approving medical devices for rare conditions

scientific article published on 17 January 2014

Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect

scientific article published on 01 February 2019

Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions

scientific article published on 31 August 2020

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval

scientific article published on 01 July 2019

Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-analysis

scholarly article published 5 April 2019

Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study

scientific article published on 07 October 2020

Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts.

scientific article published on 9 May 2016

Association of marketing interactions with medical trainees' knowledge about evidence-based prescribing: results from a national survey

scientific article published in August 2014

Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.

scientific article

Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development

scientific article published on July 2017

Availability and utilization of cardiovascular fixed-dose combination drugs in the United States.

scientific article

BIOMEDICAL RESEARCH. Countering imprecision in precision medicine

scientific article published on 01 July 2016

Balancing access and innovation: India's Supreme Court rules on imatinib

scientific article published on 01 July 2013

Balancing innovation, access, and profits--market exclusivity for biologics

scientific article

Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage

scientific article

Biomarkers unbound--the Supreme Court's ruling on diagnostic-test patents

scientific article published on 23 May 2012

Biomedical patents and the public's health: is there a role for eminent domain?

scientific article published on 01 January 2006

Both Urgency and Balance Needed in Addressing Opioid Epidemic: A Report From the National Academies of Sciences, Engineering, and Medicine

scientific article

Breakthrough Medical Devices and the 21st Century Cures Act.

scientific article published on 19 January 2016

Brief Report: Utilization of the First Biosimilar Infliximab Since Its Approval in South Korea

scientific article published on 14 December 2015

Burden of changes in generic pill appearance

article published in 2014

Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case-control studies

Challenges and Opportunities for Biomarker Validation

scientific article published on 01 September 2019

Challenges in the Development of Novel Cardiovascular Therapies

scientific article

Changes in Drug Pricing After Drug Shortages in the United States

scientific article published on 18 September 2018

Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program

scientific article published on 18 November 2020

Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015

scientific article published on 01 December 2018

Changes in Price for Generic Drugs in the USA, 2008-2016

scientific article published on 01 September 2019

Changes in direct-to-consumer pharmaceutical advertising following shifts from prescription-only to over-the-counter status

scientific article published on 01 September 2012

Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications

scientific article published on 27 April 2017

Changing interactions between physician trainees and the pharmaceutical industry: a national survey.

scientific article published on August 2013

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.

scientific article published on August 2017

Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration

scientific article published on 02 October 2019

Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer

scientific article

Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review

scientific article

Characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation

scientific article published in August 2006

Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs

scientific article published on 12 June 2019

Chemotherapy parity laws: a remedy for high drug costs?

scientific article published on 01 November 2014

Clinical Decision Support Systems Could Be Modified To Reduce ‘Alert Fatigue’ While Still Minimizing The Risk Of Litigation

article

Clinical Development Times for Biosimilars in the United States

scientific article published on 01 October 2020

Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.

scientific article published on January 2017

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.

scientific article published on January 2017

Clinical and regulatory features of drugs not initially approved by the FDA.

scientific article published on 20 August 2013

Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration

scientific article published on 22 July 2020

Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.

scientific article published on December 2008

Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation

scientific 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.

scientific article published on 17 November 2016

Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims

article

Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study.

scientific article published in September 2014

Comparative effectiveness of generic versus brand-name antiepileptic medications

scientific article published on 17 September 2015

Comparing Onset of Biosimilar Versus Generic Competition in the United States

scientific article published on 04 July 2020

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study

scientific article published on 28 June 2016

Competition and price among brand-name drugs in the same class: A systematic review of the evidence

scientific article published on 30 July 2019

Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act

scientific article published on 01 January 2019

Confidentiality Orders and Public Interest in Drug and Medical Device Litigation

scientific article published on 28 October 2019

Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.

scientific article

Conflict of Interest Disclosure in Early Education of Medical Students ⬇️

scientific article published on September 7, 2011

Conflict of interest in oncology publications: a survey of disclosure policies and statements.

scientific article published on 29 June 2011

Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures

scientific article

Contrast-induced nephropathy: how it develops, how to prevent it.

scientific article

Correction to: FDA and EMA Biosimilar Approvals

scientific article published on 05 December 2019

Correction to: Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

scientific article published on 8 March 2018

Cost Implications of Escalating Intravenous Acetaminophen Use in Children

scientific article published on 01 May 2019

Cost-effectiveness of Statin Therapy for ASCVD

scientific article published on 01 November 2015

Coverage of Magnetic Resonance Imaging for Patients With Cardiac Devices: Improving the Coverage With Evidence Development Program

scientific article published on 8 May 2017

Covert pharmaceutical promotion in free medical journals ⬇️

scientific article published on February 28, 2011

Creating a medical, ethical, and legal framework for complex living kidney donors

scientific article

Deception and presidential disability: an historical analysis.

scientific article published in December 2001

Decision-making under uncertainty: comparing regulatory and health technology assessment reviews of medicines in the US and Europe

scientific article published on 01 April 2020

Defining "True and Non-Misleading" for Pharmaceutical Promotion

scientific article published on 01 June 2018

Defining "innovativeness" in drug development: a systematic review.

scientific article published on 30 May 2013

Delayed Generic Market Saturation After Patent Expiration-A Billion-Dollar Problem

scientific article published on 01 May 2018

Designing comparative effectiveness research on prescription drugs: lessons from the clinical trial literature

scientific article published on October 2010

Desmopressin and the risk of hyponatremia: A population-based cohort study

scientific article published on 21 October 2019

Determinants of Market Exclusivity for Prescription Drugs in the United States

scientific article published on 11 September 2017

Development and use of new therapeutics for rare diseases: views from patients, caregivers, and advocates

scientific article published in January 2015

Development of a National Public Pharmaceutical Research and Development Institute

scientific article published on 01 March 2020

Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis

scientific article

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study.

scientific article published on 3 April 2018

Distributions of industry payments to Massachusetts physicians.

scientific article published in May 2013

Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study

scientific article

Do patients trust the FDA?: a survey assessing how patients view the generic drug approval process

scientific article

Does Helicobacter pylori eradication therapy to prevent gastric cancer increase all-cause mortality?

scientific article published on 26 October 2018

Drug Prices, Rebates, and Discounts

scientific article published on 01 July 2020

Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine

scientific article

Drug Shortages and the Defense Production Act

scientific article published on 01 October 2020

Drug company gifts to medical students: the hidden curriculum ⬇️

scientific article published on February 20, 2013

Drug development and FDA approval, 1938-2013.

scientific article

Drug development for neglected diseases - the trouble with FDA review vouchers.

scientific article

Drug labels: a flawed source of data for studying orphan drug approvals

scientific article published on 17 October 2012

Effect of Generic Competition on Atorvastatin Prescribing and Patients' Out-of-Pocket Spending.

scientific article published on 27 June 2016

Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System

scientific article published on 01 January 2019

Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development.

scientific article published on 8 April 2017

Effect of financial relationships on the behaviors of health care professionals: a review of the evidence.

scientific article published on January 2012

Efficacy of the Priority Review Voucher Program

scientific article published on 01 April 2016

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines

scientific article published on 24 April 2018

Electronic medication packaging devices and medication adherence: a systematic review

scientific article

Eliminating Coverage Discrimination Through the Essential Health Benefit's Anti-Discrimination Provisions

scientific article published on 01 February 2017

Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer

scientific article published on 01 April 2017

Ensuring patient privacy in data sharing for postapproval research

scientific article

Erratum to: Changing Interactions Between Physician Trainees and the Pharmaceutical Industry: A National Survey.

scientific article published on 14 June 2013

Erratum to: Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications

scientific article published on 01 September 2015

Estimating The Cost Of Delayed Generic Drug Entry To Medicaid

scientific article published on 01 June 2020

Estimation of Medicare Part D Spending on Insulin for Patients With Diabetes Using Negotiated Prices and a Defined Formulary

scientific article published on 03 February 2020

Ethical Issues in New Drug Prescribing ⬇️

scientific article published on December 15, 2011

Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels

scientific article published on 01 August 2016

Ethical and legal views of physicians regarding deactivation of cardiac implantable electrical devices: a quantitative assessment

scientific article

Ethical and legal views regarding deactivation of cardiac implantable electrical devices in patients with hypertrophic cardiomyopathy

scientific article published on 4 February 2011

Ethical considerations in orphan drug approval and use.

scientific article published in August 2012

Evaluating The Impact Of The Orphan Drug Act's Seven-Year Market Exclusivity Period

scientific article published on 01 May 2018

Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs

scientific article published on 13 April 2020

Evidence Required for Drugs Granted Accelerated Approval-Reply

scientific article published in December 2017

Evidence, errors, and ethics.

scientific article published on January 2014

Evolution of insulin patents and market exclusivities in the USA

scientific article published on 06 October 2015

Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs.

scientific article published on October 2014

Expanded access to investigational drugs

scientific article

Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health

scientific article published on 01 May 2018

Experience With the Priority Review Voucher Program for Drug Development

scientific article published on 28 September 2015

Experiences With and Challenges Afforded by Expedited Regulatory Pathways

scientific article published on 01 April 2019

Expert review of drug patent applications: improving health in the developing world

scientific article published on 25 August 2009

Extensions of intellectual property rights and delayed adoption of generic drugs: effects on medicaid spending

scientific article published in November 2006

FDA Approval and Regulation of Pharmaceuticals, 1983-2018

scientific article published on 01 January 2020

FDA Approval of Desmopressin for Nocturia

scientific article published on 6 April 2017

FDA Approval of Eteplirsen for Muscular Dystrophy-Reply

scientific article published on 01 April 2017

FDA Policy and Cardiovascular Medicine

scientific article

FDA and EMA Biosimilar Approvals

scientific article published on 02 December 2019

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

scientific article

FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.

scientific article

FDA regulation of mobile health technologies

scientific article published on 01 July 2014

FDA regulation of off-label drug promotion under attack

scientific article published on 01 February 2013

Factors Influencing Prescription Drug Costs in the United States-Reply.

scientific article

Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results

scientific article published on 10 October 2016

False Claims Act prosecution did not deter off-label drug use in the case of neurontin.

scientific article

False Negative Tests for SARS-CoV-2 Infection - Challenges and Implications

scientific article published on 05 June 2020

Federal Spending on Off-Patent Drugs That Lack Generic Competition

scientific article published on 06 March 2020

Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals ⬇️

scientific article published on September 1, 2010

Final report of the college's presidential health task force.

scientific article

Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act

scientific article published on 01 October 2019

Forbidden and Permitted Statements about Medications--Loosening the Rules

scientific article published in September 2015

Gene patenting--is the pendulum swinging back?

scientific article published on 7 April 2010

Gene patenting--the Supreme Court finally speaks

scientific article published on 10 July 2013

Generating comparative evidence on new drugs and devices before approval

scientific article published on 01 March 2020

Generic Competition for Drugs Treating Rare Diseases

scientific article published on 01 December 2020

Generic Drug Approvals Since the 1984 Hatch-Waxman Act.

scientific article published on 18 July 2016

Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices

scientific article published on 22 November 2017

Generic immunosuppressants in hematopoietic cell transplantation

scientific article

Getting the Right Evidence After Drug Approval

scientific article published on 09 September 2020

Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio

scientific article published on 01 June 2018

Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era?

scientific article published on January 2015

Health policy basics: the Physician Payment Sunshine Act and the Open Payments program

scientific article published on 29 July 2014

Heterogeneity of antidiabetic treatment effect on the risk of major adverse cardiovascular events in type 2 diabetes: a systematic review and meta-analysis

scientific article published on 29 September 2020

High Generic Drug Prices and Market Competition: A Retrospective Cohort Study.

scientific article

High-Cost Generic Drugs — Implications for Patients and Policymakers

scientific article published on 01 February 2015

High-cost generic drugs--implications for patients and policymakers

scientific article published in November 2014

How Medicare could get better prices on prescription drugs.

scientific article published on 30 July 2009

How Patent Troll Legislation Can Increase Timely Access to Generic Drugs

scientific article

How does medical device regulation perform in the United States and the European union? A systematic review

scientific article

Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases

scientific article published on 01 February 2019

Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions

scientific article published on 01 November 2019

Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes

scientific article published on 01 January 2019

Implementing U.S. Covid-19 Testing: Regulatory and Infrastructural Challenges

scientific article published on 01 September 2020

Improving antibiotic markets for long-term sustainability

scientific article published on 01 January 2011

Inaccurate Reporting of Insulin Reimbursement-Reply

scientific article published on 01 March 2016

Incentives for drug development--the curious case of colchicine

scientific article

Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working?

scientific article published on 28 January 2020

Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials

scientific article published on 23 April 2020

Influence, integrity, and the FDA: An ethical framework

scientific article published in September 2017

Innovative research methods for studying treatments for rare diseases: methodological review

scientific article

Insulin access and affordability in the USA: anticipating the first interchangeable insulin product

scientific article published on 20 March 2020

Insulin patents and market exclusivities: unresolved issues--Authors' reply

scientific article published on 01 February 2016

Intellectual property policy in the pharmaceutical sciences: the effect of inappropriate patents and market exclusivity extensions on the health care system

scientific article published on 03 August 2007

Internal Medicine Physicians' Financial Relationships with Industry: An Updated National Estimate

article

Internet Searches for Unproven COVID-19 Therapies in the United States

scientific article published on 29 April 2020

Introduction to a supplement on innovative approaches to studying health outcomes in rare diseases.

scientific article

Introduction: insights from a National Conference: "conflicts of interest in the practice of medicine".

scientific article published in January 2012

Journey of Generic Imatinib: A Case Study in Oncology Drug Pricing.

scientific article published on 26 April 2017

Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012

scientific article published on 01 November 2018

Landscape of Cardiovascular Device Registries in the United States.

scientific article published in June 2019

Legal Challenges to State Drug Pricing Laws

scientific article published on 12 February 2018

Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany

scientific article published on 01 July 2020

Leveraging Novel and Existing Pathways to Approve New Therapeutics to Treat Serious Drug-Resistant Infections

scientific article

Life cycle of medical product rules issued by the US Food and Drug Administration.

scientific article published on 19 May 2014

Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine

scientific article published on 22 November 2019

Low-Dose Desmopressin Nasal Spray and FDA Approval-Reply.

scientific article published in September 2017

Lung Cancer Survival Gains: Contributions of Academia and Industry

scientific article published on 01 September 2019

Major Events in the Life Course of New Drugs, 2000-2016

scientific article published on 01 March 2019

Managing financial and nonfinancial conflicts of interest in healthcare delivery

scientific article

Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues

scientific article

Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012-2018

scientific article published on 12 July 2020

Market-based licensing for HPV vaccines in developing countries

scientific article published on 01 January 2008

Massachusetts' Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage?

scientific article published on 13 December 2017

Media Coverage of FDA Drug Safety Communications about Zolpidem: A Quantitative and Qualitative Analysis

scientific article published on 24 March 2017

Medicaid Expenditures and Estimated Rebates for Epinephrine Autoinjectors, 2012 to 2016.

scientific article published in May 2017

Medical Schools' Industry Interaction Policies Not Associated With Trainees' Self-Reported Behavior as Residents: Results of a National Survey

scientific article

Medical device postapproval safety monitoring: where does the United States stand?

scientific article

Medical innovation then and now: perspectives of innovators responsible for transformative drugs

scientific article published on January 2014

Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review

scientific article

Medical-process patents--monopolizing the delivery of health care

scientific article published in November 2006

Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents

scientific article published on 01 August 2018

Meta-analyses involving cross-over trials: methodological issues

scientific article published on 21 December 2009

Methodological approaches to evaluate the impact of FDA drug safety communications

scientific article published in June 2015

Missed Opportunities on Emergency Remdesivir Use

scientific article published on 24 June 2020

Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.

scientific article published on April 2015

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem

scientific article published on 01 November 2019

Navigating the Dermatological Drug Cost Curve

scientific article published on 01 June 2016

Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies

scientific article published on 19 May 2020

New "21st Century Cures" Legislation: Speed and Ease vs Science

scientific article published in February 2017

New Drug Formulations and Their Respective Generic Entry Dates

scientific article published on 01 February 2019

New FDA breakthrough-drug category--implications for patients

scientific article published on 01 July 2014

New FDA breakthrough-drug category--implications for patients.

scientific article

New and unproved medical devices.

scientific article published on 19 December 2013

New drug approvals in oncology

scientific article published on 04 February 2020

Non-Warfarin Oral Anticoagulant Copayments and Adherence in Atrial Fibrillation:A Population-Based Cohort Study

scientific article published on 21 December 2020

Novelty of Active Ingredients in High-Cost Brand-Name Drugs

scientific article published on 02 January 2020

Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech ⬇️

scientific article published on 01 January 2011

Origins and Ownership of Remdesivir: Implications for Pricing

scientific article published on 01 September 2020

Origins of medical innovation: the case of coronary artery stents.

scientific article published on 23 October 2012

Orphan Drug Designation and Exclusivity for "Same Drugs"

scientific article published on 01 June 2019

Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.

scientific article published on 08 February 2017

Outcomes-Based Pharmaceutical Contracts: An Answer to High U.S. Drug Spending?

scientific article published in September 2017

Overbilling vs. downcoding--the battle between physicians and insurers

scientific article published in March 2005

Pain Management and Opioid Regulation: Continuing Public Health Challenges

article

Patent term restoration for top-selling drugs in the United States

scientific article published on 25 July 2018

Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study

scientific article published on 28 February 2017

Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey

scientific article published on 01 September 2019

Patterns and predictors of generic narrow therapeutic index drug use among older adults.

scientific article published on 3 September 2013

Paying for Tissue: Net Benefits--Response

scientific article published in Science

Paying for innovation: reimbursement incentives for antibiotics

scientific article published on 01 February 2015

Paying physicians to prescribe generic drugs and follow-on biologics in the United States.

scientific article

Payments to Physicians, Prescribing Rates, and More Appropriate Conclusions-Reply

scientific article published on 01 October 2016

Periodic benefit-risk evaluation reports have substantial promise to guide patient care and should be made publicly available.

scientific article published on 15 February 2017

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety

scientific article published on 01 June 2010

Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship

scientific article published in January 2018

Pharmaceutical Protections in U.S. Trade Deals - What Do Americans Get in Return?

scientific article published on 01 May 2019

Pharmaceutical marketing and the new social media

scientific article published in November 2010

Pharmaceutical promotion to physicians and First Amendment rights

scientific article published on 01 April 2008

Pharmacy Benefit Managers: Practices, Controversies, and What Lies Ahead

scientific article published on 01 March 2019

Physician Perceptions of Step Therapy Prescribing Requirements

scientific article published on 01 November 2019

Physician trainees' interactions with the pharmaceutical industry

scientific article published on October 2013

Physicians and Insider Trading

scientific article published on 12 October 2015

Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation.

scientific article

Physicians' Perspectives on FDA Approval Standards and Off-label Drug Marketing

scientific article published on 01 May 2019

Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval

scientific article

Postmarket surveillance of medical devices: a comparison of strategies in the US, EU, Japan, and China.

scientific article

Postmarketing trials and pediatric device approvals. ⬇️

scientific article

Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers

scientific article published on 05 August 2019

Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary

scientific article published on 02 December 2019

Practical, legal, and ethical issues in expanded access to investigational drugs

scientific article

Pre-market development times for biologic versus small-molecule drugs

scientific article published on 01 July 2019

Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines

scientific article published on 01 May 2018

Precision medicine and the FDA's draft guidance on laboratory-developed tests

scientific article published on 01 May 2015

Predictors of Drug Shortages and Association with Generic Drug Prices: A Retrospective Cohort Study

scientific article published on 18 May 2018

Preferences for and experiences with pill appearance changes: national surveys of patients and pharmacists

scientific article published on 01 August 2020

Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study

scientific article published on 31 March 2020

Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications

scientific article published on 02 November 2019

Prescription Trends-Brand-Name Drugs vs Generic-Reply

scientific article published on 01 October 2016

Prescription drug insurance coverage and patient health outcomes: a systematic review

scientific article published on 01 February 2015

Prescription-drug coupons--no such thing as a free lunch

scientific article

Prevalence and Predictors of Generic Drug Skepticism Among Physicians: Results of a National Survey

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Prevalence of Publicly Available Expanded Access Policies

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Price Increases of Protected-Class Drugs in Medicare Part D, Relative to Inflation, 2012-2017

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Prices and clinical benefit of cancer drugs in the USA and Europe: a cost-benefit analysis

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Prices of Generic Drugs Associated with Numbers of Manufacturers

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Prioritization of Generic Drug Review-Reply

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Priority review vouchers: an inefficient and dangerous way to promote neglected-disease drug development.

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Producing and using timely comparative evidence on drugs: lessons from clinical trials for covid-19

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Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness

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Professional oversight of physician expert witnesses: an analysis of complaints to the Professional Conduct Committee of the American Association of Neurological Surgeons, 1992-2006.

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Progress and Hurdles for Follow-on Biologics

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Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015.

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Projected spending for brand-name drugs in English primary care given US prices: a cross-sectional study

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Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation

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Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations?

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Propofol as a transformative drug in anesthesia: insights from key early investigators

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Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad

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Public funding for transformative drugs: the case of sofosbuvir

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Public sector financial support for late stage discovery of new drugs in the United States: cohort study

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Quantifying The Food And Drug Administration's rulemaking delays highlights the need for transparency.

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Questions about the 10 x '20 Initiative

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Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion

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Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018

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Reconsidering the scope of US state laws allowing pharmacist substitution of generic drugs

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Reforming the Orphan Drug Act for the 21st Century

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Regulating Homeopathic Products - A Century of Dilute Interest

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Regulating Off-Label Promotion - A Critical Test

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Regulation of medical devices in the United States and European Union

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Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency

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Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals

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Regulatory Solutions to the Problem of High Generic Drug Costs

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Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities

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Reply to Boucher, et al

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Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations

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Reputation and precedent in the bevacizumab decision

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Restrictions on pharmaceutical detailing reduced off-label prescribing of antidepressants and antipsychotics in children

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Rethinking global access to vaccines

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Review times and adverse events for cardiovascular devices

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Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government Support

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Safety, Supply, and Suits — Litigation and the Vaccine Industry ⬇️

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Scientific and legal viability of follow-on protein drugs

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Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers.

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Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.

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Social, cultural and economic aspects of antimicrobial resistance

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Specialty Drugs - A Distinctly American Phenomenon

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Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI.

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Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis

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State Initiatives to Control Medication Costs--Can Transparency Legislation Help?

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State generic substitution laws can lower drug outlays under Medicaid

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Strategies That Delay Market Entry of Generic Drugs

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Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints

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Strategies for postmarketing surveillance of drugs for rare diseases.

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Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors

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Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence

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Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence

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Temporal Trends and Factors Associated With Cardiovascular Drug Development, 1990 to 2012.

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Tepid Steps on Drug Pricing

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Tertiary patenting on drug-device combination products in the United States

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The 21st century cures act: Opportunities and challenges

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The FDA Amendments Act of 2007 - Assessing Its Effects a Decade Later

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The FDA Breakthrough-Drug Designation - Four Years of Experience

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The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.

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The FDA, Juno Therapeutics, and the ethical imperative of transparency.

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The Failure of Solanezumab - How the FDA Saved Taxpayers Billions

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The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness research.

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The Food and Drug Administration's role in promoting consistent labels for generic drugs

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The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents

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The High Cost of Prescription Drugs in the United States

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The Price of Crossing the Border for Medications

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The Real-World Ethics of Adaptive-Design Clinical Trials

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The Supreme Court, preemption, and malpractice liability

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The Supreme Court, process patents, and medical innovation

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The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry

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The US Biosimilar Market: Stunted Growth and Possible Reforms

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The ethics of intellectual property rights in an era of globalization

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The evidence landscape in precision medicine

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The evolving role of biomarker patents in personalized medicine.

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The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients

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The medical device excise tax--over before it begins?

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The role of litigation in defining drug risks

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The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs.

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The variability and quality of medication container labels

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Think globally, prescribe locally: how rational pharmaceutical policy in the U.S. can improve global access to essential medicines

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Three design aspects for high quality post-marketing cohort studies

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Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis

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Translational research and the U.S. federal elections

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Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014.

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Trends in Medicare Part D Inhaler Spending, 2012-2018

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Trends in pricing and generic competition within the oral antibiotic drug market in the United States.

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Two decades of new drug development for central nervous system disorders

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US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals

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University-based science and biotechnology products: defining the boundaries of intellectual property.

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Up Is Down - Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval

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Use the Bayh-Dole Act to lower drug prices for government healthcare programs

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User fees and beyond--the FDA Safety and Innovation Act of 2012

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Using a drug-safety tool to prevent competition

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Using malpractice claims to identify risk factors for neurological impairment among infants following non-reassuring fetal heart rate patterns during labour.

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Using patent data to assess the value of pharmaceutical innovation

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Using real-world safety data in regulatory approval decisions: Sotagliflozin and the risk of diabetic ketoacidosis

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Value-Based Pricing and State Reform of Prescription Drug Costs.

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Variations in time of market exclusivity among top-selling prescription drugs in the United States

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Whistle-blowers' experiences in fraud litigation against pharmaceutical companies

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Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005.

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Will inter partes review speed US generic drug entry?

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Will physician-level measures of clinical performance be used in medical malpractice litigation?

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