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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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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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Other

First published 2007-1

Continuous Marketing Applications: Experiences of Three Biotechnology Companies

Christine Boisclair, Meg Casais, MaryAnn Foote [...]

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 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 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 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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