Mayookha Mitra-Majumdar

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

Jonathan J. Darrow, Murray N. Ross, A. Kesselheim, 2022, Drug Safety.

Reporting bias in clinical trials: Progress toward transparency and next steps

A. Kesselheim, Mayookha Mitra-Majumdar, 2022, PLoS medicine.

Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020

Jonathan J. Darrow, Murray N. Ross, A. Kesselheim, 2022, JAMA network open.

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

A. Kesselheim, J. Avorn, J. Gagne, 2021, Drug Safety.

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

Jonathan J. Darrow, M. Kulldorff, A. Kesselheim, 2020, Health affairs.

Evidence at time of regulatory approval and cost of new antibiotics in 2016-19: cohort study of FDA approved drugs

A. Kesselheim, J. Powers, B. L. Brown, 2022, BMJ medicine.

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.

Jonathan J. Darrow, A. Kesselheim, J. Avorn, 2022, JAMA internal medicine.