Works by Kesselheim, Aaron S.

Results: 493

Medicare spending and use of subcutaneous biologic formulations with hyaluronidase.

Published in:

Oncologist, 2025, v. 30, n. 6, p. 1, doi. 10.1093/oncolo/oyaf149

By:

Kim, John;
Kesselheim, Aaron S;
Cliff, Edward R Scheffer;
Rome, Benjamin N

Publication type:

Article

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

Published in:

2020

By:

Lin, Kueiyu Joshua;
Dvorin, Evan;
Kesselheim, Aaron S.

Publication type:

journal article

Use of Omalizumab for Pediatric Asthma After US Food and Drug Administration Expanded Indications.

Published in:

Pharmacoepidemiology & Drug Safety, 2024, v. 33, n. 10, p. 1, doi. 10.1002/pds.70009

By:

Deshmukh, Anjali D.;
Kesselheim, Aaron S.;
Tsacogianis, Theodore;
Rome, Benjamin N.

Publication type:

Article

Correlation Between Changes in Brand-Name Drug Prices and Patient Out-of-Pocket Costs.

Published in:

JAMA Network Open, 2021, v. 4, n. 5, p. e218816, doi. 10.1001/jamanetworkopen.2021.8816

By:

Rome, Benjamin N.;
Feldman, William B.;
Desai, Rishi J.;
Kesselheim, Aaron S.

Publication type:

Article

Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020.

Published in:

JAMA Network Open, 2021, v. 4, n. 4, p. e218530, doi. 10.1001/jamanetworkopen.2021.8530

By:

Moneer, Osman;
Lee, ChangWon C.;
Avorn, Jerry;
Kesselheim, Aaron S.

Publication type:

Article

Limitations on the Capability of the FDA to Advise.

Published in:

American Journal of Bioethics, 2022, v. 22, n. 10, p. 15, doi. 10.1080/15265161.2022.2110978

By:

Rand, Leah Z.;
Kesselheim, Aaron S.

Publication type:

Article

The Effects of the Sunshine Act: What Can and Should We Expect?

Published in:

American Journal of Bioethics, 2017, v. 17, n. 6, p. 22, doi. 10.1080/15265161.2017.1316787

By:

Sinha, Michael S.;
Kesselheim, Aaron S.

Publication type:

Article

New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.

Published in:

Drug Safety, 2022, v. 45, n. 4, p. 305, doi. 10.1007/s40264-022-01152-9

By:

Moneer, Osman;
Brown, Beatrice L.;
Avorn, Jerry;
Darrow, Jonathan J.;
Mitra-Majumdar, Mayookha;
Joyce, Krysten W.;
Ross, Murray;
Pham, Catherine;
Kesselheim, Aaron S.

Publication type:

Article

A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.

Published in:

Drug Safety, 2021, v. 44, n. 7, p. 743, doi. 10.1007/s40264-021-01070-2

By:

Sarpatwari, Ameet;
Mitra-Majumdar, Mayookha;
Bykov, Katsiaryna;
Avorn, Jerry;
Woloshin, Steven;
Toyserkani, Gita A.;
LaCivita, Cynthia;
Manzo, Claudia;
Zhou, Esther H.;
Pinnow, Ellen;
Dal Pan, Gerald J.;
Gagne, Joshua J.;
Huybrechts, Krista F.;
Feldman, William B.;
Chin, Kristyn;
Kesselheim, Aaron S.

Publication type:

Article

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

Published in:

2021

By:

Sarpatwari, Ameet;
He, Mengdong;
Tessema, Frazer A.;
Gagne, Joshua J.;
Kesselheim, Aaron S.

Publication type:

journal article

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

Published in:

2020

By:

Barenie, Rachel E.;
Gagne, Joshua J.;
Kesselheim, Aaron S.;
Pawar, Ajinkya;
Tong, Angela;
Luo, Jing;
Bateman, Brian T.

Publication type:

journal article

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.

Published in:

2019

By:

Kesselheim, Aaron S.;
Sinha, Michael S.;
Campbell, Eric G.;
Schneeweiss, Sebastian;
Rausch, Paula;
Lappin, Brian M.;
Zhou, Esther H.;
Avorn, Jerry;
Dal Pan, Gerald J.

Publication type:

journal article

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

Published in:

Drug Safety, 2019, v. 42, n. 1, p. 85, doi. 10.1007/s40264-018-0703-x

By:

Rogers, James R.;
Sarpatwari, Ameet;
Desai, Rishi J.;
Bohn, Justin M.;
Khan, Nazleen F.;
Kesselheim, Aaron S.;
Fischer, Michael A.;
Gagne, Joshua J.;
Connolly, John G.

Publication type:

Article

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

Published in:

2018

By:

Mundkur, Mallika L.;
Franklin, Jessica;
Huybrechts, Krista F.;
Fischer, Michael A.;
Kesselheim, Aaron S.;
Linder, Jeffrey A.;
Landon, Joan;
Patorno, Elisabetta

Publication type:

journal article

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

Published in:

2018

By:

Rogers, James R;
Sarpatwari, Ameet;
Desai, Rishi J;
Bohn, Justin M;
Khan, Nazleen F;
Kesselheim, Aaron S;
Fischer, Michael A;
Gagne, Joshua J;
Connolly, John G

Publication type:

journal article

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

Published in:

2017

By:

Kesselheim, Aaron;
McGraw, Sarah;
Dejene, Sara;
Rausch, Paula;
Dal Pan, Gerald;
Lappin, Brian;
Zhou, Esther;
Avorn, Jerry;
Campbell, Eric;
Kesselheim, Aaron S;
McGraw, Sarah A;
Dejene, Sara Z;
Dal Pan, Gerald J;
Lappin, Brian M;
Zhou, Esther H;
Campbell, Eric G

Publication type:

journal article

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

Published in:

2017

By:

Sarpatwari, Ameet;
Gagne, Joshua;
Levidow, Nicole;
Kesselheim, Aaron;
Gagne, Joshua J;
Levidow, Nicole L;
Kesselheim, Aaron S

Publication type:

journal article

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

Published in:

2016

By:

Yeh, James;
Sarpatwari, Ameet;
Kesselheim, Aaron;
Yeh, James S;
Kesselheim, Aaron S

Publication type:

journal article

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

Published in:

2015

By:

Kesselheim, Aaron;
Gagne, Joshua;
Kesselheim, Aaron S;
Gagne, Joshua J

Publication type:

journal article

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

Published in:

2015

By:

Kesselheim, Aaron S;
Campbell, Eric G;
Schneeweiss, Sebastian;
Rausch, Paula;
Lappin, Brian M;
Zhou, Esther H;
Seeger, John D;
Brownstein, John S;
Woloshin, Steven;
Schwartz, Lisa M;
Toomey, Timothy;
Dal Pan, Gerald J;
Avorn, Jerry

Publication type:

corrected article

Methodological approaches to evaluate the impact of FDA drug safety communications.

Published in:

2015

By:

Kesselheim, Aaron S;
Campbell, Eric G;
Schneeweiss, Sebastian;
Rausch, Paula;
Lappin, Brian M;
Zhou, Esther H;
Seeger, John D;
Brownstein, John S;
Woloshin, Steven;
Schwartz, Lisa M;
Toomey, Timothy;
Dal Pan, Gerald J;
Avorn, Jerry

Publication type:

journal article

Medicare Negotiation's Drug Reformulation Problem.

Published in:

2024

By:

Vogel, Matthew;
Rome, Benjamin N.;
Kesselheim, Aaron S.;
Feldman, William B.

Publication type:

Editorial

Estimated Medicare Part D Savings From Generic Drugs With a Skinny Label.

Published in:

Annals of Internal Medicine, 2024, v. 177, n. 6, p. 833, doi. 10.7326/M23-3212

By:

Egilman, Alexander C.;
Kesselheim, Aaron S.;
Sarpatwari, Ameet;
Rome, Benjamin N.

Publication type:

Article

Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease.

Published in:

Annals of Internal Medicine, 2024, v. 177, n. 1, p. 1, doi. 10.7326/L23-0429

By:

Feldman, William B.;
Kesselheim, Aaron S.;
Avorn, Jerry;
Russo, Massimiliano;
Wang, Shirley V.

Publication type:

Article

Changes in Induced Medical and Procedural Abortion Rates in a Commercially Insured Population, 2018 to 2022: An Interrupted Time-Series Analysis.

Published in:

Annals of Internal Medicine, 2023, v. 176, n. 11, p. 1508, doi. 10.7326/M23-1609

By:

Hwang, Catherine S.;
Kesselheim, Aaron S.;
Sarpatwari, Ameet;
Huybrechts, Krista F.;
Brill, Gregory;
Rome, Benjamin N.

Publication type:

Article

Regulatory Review Duration and Differences in Submission Times of Drugs in the United States and Europe, 2011 to 2020.

Published in:

Annals of Internal Medicine, 2023, v. 176, n. 10, p. 1413, doi. 10.7326/M23-0623

By:

Vokinger, Kerstin N.;
Serra-Burriel, Miquel;
Glaus, Camille E.G.;
Rohr, Ulrich-Peter;
Hwang, Thomas J.;
Dalla Torre di Sanguinetto, Simon;
Kesselheim, Aaron S.

Publication type:

Article

The Regulatory Repercussions of Approving Muscular Dystrophy Medications on the Basis of Limited Evidence.

Published in:

Annals of Internal Medicine, 2023, v. 176, n. 9, p. 1251, doi. 10.7326/M23-1073

By:

Bendicksen, Liam;
Zuckerman, Diana M.;
Avorn, Jerry;
Phillips, Sophia;
Kesselheim, Aaron S.

Publication type:

Article

Moving Naloxone Over the Counter Is Necessary but Not Sufficient.

Published in:

Annals of Internal Medicine, 2023, v. 176, n. 8, p. 1109, doi. 10.7326/M23-0852

By:

Messinger, John C.;
Beletsky, Leo;
Kesselheim, Aaron S.;
Barenie, Rachel E.

Publication type:

Article

Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease.

Published in:

Annals of Internal Medicine, 2023, v. 176, n. 8, p. 1047, doi. 10.7326/M23-0615

By:

Feldman, William B.;
Kesselheim, Aaron S.;
Avorn, Jerry;
Russo, Massimiliano;
Wang, Shirley V.

Publication type:

Article

Potential Medicare Part D Savings on Generic Drugs From the Mark Cuban Cost Plus Drug Company.

Published in:

2022

By:

Lalani, Hussain S.;
Kesselheim, Aaron S.;
Rome, Benjamin N.

Publication type:

research

Direct-to-Consumer Generic Drugs: A Maverick Approach or Another Exposure of Market Failures?

Published in:

2022

By:

Lalani, Hussain S;
Kesselheim, Aaron S;
Rome, Benjamin N

Publication type:

Editorial

Independent Advice on Drug Approvals: an Investigation of EMA Practices.

Published in:

JGIM: Journal of General Internal Medicine, 2024, v. 39, n. 2, p. 345, doi. 10.1007/s11606-023-08495-8

By:

Daval, C. Joseph Ross;
Kesselheim, Aaron S.;
Sharpless, Leigh;
Sarpatwari, Ameet

Publication type:

Article

Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.

Published in:

JGIM: Journal of General Internal Medicine, 2022, v. 37, n. 16, p. 4176, doi. 10.1007/s11606-021-07316-0

By:

Dhruva, Sanket S.;
Darrow, Jonathan J.;
Kesselheim, Aaron S.;
Redberg, Rita F.

Publication type:

Article

Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018.

Published in:

2022

By:

Hwang, Thomas J.;
Feng, Josh;
Maini, Luca;
Kesselheim, Aaron S.

Publication type:

Letter

Characteristics of US Patients and Prescribers Using Hydroxychloroquine During the COVID-19 Pandemic.

Published in:

2021

By:

Rome, Benjamin N.;
Avorn, Jerry;
Kesselheim, Aaron S.

Publication type:

Letter

Variations in Generic Combination Opioid Use Across State Medicaid Programs.

Published in:

2021

By:

Lee, ChangWon C.;
Kesselheim, Aaron S.;
Avorn, Jerry

Publication type:

journal article

Federal Spending on Off-Patent Drugs That Lack Generic Competition.

Published in:

2021

By:

Rome, Benjamin N.;
Kesselheim, Aaron S.

Publication type:

Letter

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

Published in:

2020

By:

Jung, Emily H.;
Sarpatwari, Ameet;
Kesselheim, Aaron S.

Publication type:

journal article

FDA and EMA Biosimilar Approvals.

Published in:

2020

By:

Jung, Emily H.;
Sarpatwari, Ameet;
Kesselheim, Aaron S.;
Sinha, Michael S.

Publication type:

journal article

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

Published in:

2019

By:

Dave, Chintan V.;
Patorno, Elisabetta;
Franklin, Jessica M.;
Huybrechts, Krista;
Sarpatwari, Ameet;
Kesselheim, Aaron S.;
Bateman, Brian T.

Publication type:

Letter

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

Published in:

2019

By:

Dave, Chintan V.;
Brill, Gregory;
Kesselheim, Aaron S.

Publication type:

Letter

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

Published in:

2019

By:

Sarpatwari, Ameet;
Gagne, Joshua J.;
Lu, Zhigang;
Campbell, Eric G.;
Carman, Wendy J.;
Enger, Cheryl L.;
Dutcher, Sarah K.;
Jiang, Wenlei;
Kesselheim, Aaron S.

Publication type:

journal article

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

Published in:

2019

By:

Kesselheim, Aaron S.;
Woloshin, Steven;
Lu, Zhigang;
Tessema, Frazer A.;
Ross, Kathryn M.;
Schwartz, Lisa M.

Publication type:

journal article

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

Published in:

2018

By:

Fralick, Michael;
Avorn, Jerry;
Franklin, Jessica M.;
Bartsch, Emily;
Abdurrob, Abdurrahman;
Kesselheim, Aaron S.

Publication type:

Letter

Application and impact of run-in studies.

Published in:

2018

By:

Fralick, Michael;
Avorn, Jerry;
Franklin, Jessica M.;
Abdurrob, Abdurrahman;
Kesselheim, Aaron S.

Publication type:

journal article

Variations in Patients' Perceptions and Use of Generic Drugs: Results of a National Survey.

Published in:

2016

By:

Kesselheim, Aaron;
Gagne, Joshua;
Franklin, Jessica;
Eddings, Wesley;
Fulchino, Lisa;
Avorn, Jerry;
Campbell, Eric;
Kesselheim, Aaron S;
Gagne, Joshua J;
Franklin, Jessica M;
Fulchino, Lisa A;
Campbell, Eric G

Publication type:

journal article

Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population.

Published in:

2015

By:

Kesselheim, Aaron;
Franklin, Jessica;
Kim, Seoyoung;
Seeger, John;
Solomon, Daniel;
Kesselheim, Aaron S;
Franklin, Jessica M;
Kim, Seoyoung C;
Seeger, John D;
Solomon, Daniel H

Publication type:

journal article

Physician trainees' interactions with the pharmaceutical industry.

Published in:

2013

By:

Austad, Kirsten E;
Avorn, Jerry;
Franklin, Jessica M;
Kesselheim, Aaron S

Publication type:

Letter

Design Patents: A Potential Threat to Drug Competition.

Published in:

Applied Health Economics & Health Policy, 2025, v. 23, n. 4, p. 531, doi. 10.1007/s40258-025-00967-8

By:

Freilich, Janet;
Kesselheim, Aaron S.

Publication type:

Article

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

Published in:

Applied Health Economics & Health Policy, 2019, v. 17, n. 1, p. 47, doi. 10.1007/s40258-018-0420-8

By:

Darrow, Jonathan J.;
Beall, Reed F.;
Kesselheim, Aaron S.

Publication type:

Article