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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 2008-1

A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments

Michelle Folz, Mark Bokelman, Thomas H. Hassall [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2008-08

Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies;Availability

Biotechnology Law Report

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Other

First published 2008-1

Introduction: PhRMA's Best Practices Initiative on FDA's Good Review Management Practices

J. Michael Maher

Therapeutic Innovation & Regulatory Science

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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 2013-11

Legal Requirements,Definitions,and Standards for Non-interventional Drug Studies

Markus Hartmann, Patricia Schaffner

Therapeutic Innovation & Regulatory Science

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Research article

First published 2002-8

Should doctors be prescribing new drugs?

Joel Lexchin

International Journal of Risk & Safety in Medicine

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Research article

First published 1991-10

Postmarketing Surveillance: Lessons Learned

Gerald A. Faich

Therapeutic Innovation & Regulatory Science

Free access

Review article

First published 2013-10

Preparing for safety issues following drug approval: pre-approval risk management considerations

Gretchen S. Dieck, Robert G. Sharrar

Therapeutic Advances in Drug Safety

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Research article

First published 2017-11

Dose Finding in Late-Phase Drug Development

Lei Nie, Kyung Y. Lee, Nicole Verdun [...]

Therapeutic Innovation & Regulatory Science

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