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Research article

First published 2007-9

The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis

James B. Graham, Ernst R. Berndt

Therapeutic Innovation & Regulatory Science

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Research article

First published 2008-08

Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan

Biotechnology Law Report

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Research article

First published 2018-4

The Prescription Drug User Fee Act: Cause for Concern?

Michael Gabay

Hospital Pharmacy

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Research article

First published 2012-1

Improving Time to Pharmaceutical Approval

Andrea C. Masciale, Patricia L. DeSantis, Jay P. Siegel

Therapeutic Innovation & Regulatory Science

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Other

First published 2004-1

Pharmacoepidemiology in Safety Evaluations of Newly Approved Medications

Elane M. Gutterman

Therapeutic Innovation & Regulatory Science

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Other

First published 2000-1

Roles of Regulatory Project Managers in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research

Jean A. Yager, Deborah L. Kallgren

Therapeutic Innovation & Regulatory Science

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Other

First published 2008-1

Best Practices for Communication between FDA and Applicants during the NDA Review Cycle: A PhRMA White Paper

David M. Cocchetto, Jennifer L. Stotka, Diane Zezza [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 2008-7

Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors

Mary Vanderhoof, Michael J. Umen, David N. Schwartz

Therapeutic Innovation & Regulatory Science

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Other

First published 2000-7

Measuring the Pace of New Drug Development in the User Fee ERA

Kenneth I. Kaitin, Joseph A. DiMasi

Therapeutic Innovation & Regulatory Science

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Other

First published 2001-1

The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

Janice M. Reichert, Jennifer Chee, Claire S. Kotzampaltiris

Therapeutic Innovation & Regulatory Science

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