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Research article

First published 2018-11

Regional Approaches to Expedited Drug Development and Review

Elizabeth Richardson, Gregory Daniel, David R. Joy [...]

Therapeutic Innovation & Regulatory Science

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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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Article commentary

First published 2019-9

21st-Century Oncology Drug Safety via New-Age Regulatory Standards and Practices

Peter J. Pitts, Hervé Le Louet, Gregory Katz

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-5

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

Thomas J. Hwang, Aaron S. Kesselheim

American Journal of Law & Medicine

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Editorial

First published 2018-9

From the Valley of Death to the Crossroads of Opportunity

Peter J. Pitts, Patrick Brady

Therapeutic Innovation & Regulatory Science

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Research article

First published 2005-1

Scientific Issues for Biogenerics/Biosimilars

Robert I. Roth, Nicholas M. Fleischer

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Review article

First published 2019-7

Regulatory Trends in Drug Development in Asia Pacific

Fengyun (Vicky) Han, Karen Weiss

Therapeutic Innovation & Regulatory Science

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Research article

First published 2018-5

Real-World Data Analytics Fit for Regulatory Decision-Making

Sebastian Schneeweiss, Robert J. Glynn

American Journal of Law & Medicine

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Research article

First published 2025-12

Regulatory Approval of CBRN Medical Countermeasures: Current Scenario and Way Ahead

Manan Grover, Mansi Sharma, Vikesh Kumar Shukla [...]

Health Security

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Research article

First published 2026

Evidence supporting European Medicines Agency drug approvals (2020–2023): A cross-sectional study of trial design and outcomes

Maximilian Siebert, Laura Caquelin, Florian Naudet [...]

Clinical Trials

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