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Research article

First published 2026

Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making,2016–2024

Louis Y Li, Reshma Ramachandran, Joseph S Ross [...]

Clinical Trials

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Research article

First published 2021-8

US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments,2009–2018

Joshua J Skydel, Audrey D Zhang, Sanket S Dhruva [...]

Clinical Trials

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Other

First published 2008-9

Government Announces Initiative to Build New Evidence on Postmarket Safety and Effectiveness of Drugs

Canadian Pharmacists Journal / Revue des Pharmaciens du Canada

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Research article

First published 2018-11

Outdated Prescription Drug Labeling

Michael B. Shea, Mark Stewart, Hugo Van Dyke [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-11

The Use of Real-World Evidence and Data in Clinical Research and Postapproval Safety Studies

Mary Jo Lamberti, Wayne Kubick, Josephine Awatin [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

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Research article

First published 2021-1

Analysis of a Unique Postmarket Surveillance Dataset That a Glucose Test-Strip Demonstrates no Evidence of Interference and Robust Clinical Accuracy Irrespective of the Prescription Medication Status of a Large Cohort of Patients With Diabetes

Mike Grady, Hilary Cameron, Stuart Phillips [...]

Journal of Diabetes Science and Technology

Free access

Research article

First published 2020-6

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Rui Duan, Xinyuan Zhang, Jingcheng Du [...]

Health Informatics Journal

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

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Research article

First published 1995-1

The Timeliness of New Drug Approvals in Canada: A Rejoinder

Joel Lexchin

International Journal of Social Determinants of Health and Health Services

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