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Retricted access

Research article

First published 2014-5

Comparison of Drug Approvals in Europe Versus the United States

Robert W. Makuch, Ruizhi Shi

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-1

Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration,2010-2015

Kyu Chan Kwon, Chulung Lee

Therapeutic Innovation & Regulatory Science

Retricted access

Brief report

First published 2022-06

Moo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human Consumption

Steven J. Zweig

Biotechnology Law Report

Free access

Research article

First published 2003-9

The Use of Unallowed Excipients

Marshall Steinberg, Irwin Silverstein

International Journal of Toxicology

Retricted access

Review article

First published 2019

How Do Drug Regulatory Bodies Deal With Potential Innovative Therapies?

Michaela Tutone, Federico Villa, Antonio Addis [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 2008-1

Assessing the Performance of the EMEA's Centralized Procedure: A Comparative Analysis with the US FDA

Laura B. Faden, Kenneth I. Kaitin

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2013-1

Regulatory Challenges for Cartilage Repair Technologies

Kevin B. McGowan, Glenn Stiegman

CARTILAGE

Retricted access

Research article

First published 2019-12

The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation

Alexander Khoruts, Diane E. Hoffmann, Francis B. Palumbo

The Journal of Law,Medicine & Ethics

Retricted access

Other

First published 1999-4

FDA Approval of Antiretroviral Agents: An Evolving Paradigm

Rachel E. Behrman

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2019

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals

Cameron M. Kieffer, Alexis Reisin Miller, Benjamin Chacko [...]

Therapeutic Innovation & Regulatory Science

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