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First published 2010-7

Overview of the FDA Amendments Act of 2007: Its Effect on the Drug Development Landscape

Raj Kishore, Edward Tabor

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2008-7

Increasing Transparency at the FDA: The Impact of the FDA Amendments Act of 2007

Susan F. Wood, Kristen L. Perosino

Public Health Reports®

Retricted access

Review article

First published 2014-3

Pediatric Exclusivity

Donna R. Rivera, Abraham G. Hartzema

Annals of Pharmacotherapy

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Other

First published 2010-5

Clinical Trial Disclosure: Global Overview and Implications of New Laws and Guidelines

Kathy B. Thomas, Merete Joergensen, Gerard Lynch [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2013-1

How FDA Advisory Committee Members Prepare and What Influences Them

Todd D. McIntyre, Mimi Pappas, James J. DiBiasi

Therapeutic Innovation & Regulatory Science

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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 2014-4

Medication Safety and Pharmacovigilance Resources for the Ambulatory Care Setting: Enhancing Patient Safety

Jennifer A. Gershman, Andrea D. Fass

Hospital Pharmacy

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Other

First published 2009-9

Constant Vigilance: The Role of Pharmaceutical Companies in Medicine Safety

Gretchen S. Dieck, Susan Betger, Daniel A. Kracov [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2013-04

Risk Evaluation Mitigation Strategies: The Evolution of Risk Management Policy

Kristen Hollingsworth, Michael Toscani

Population Health Management

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Other

First published 2009-11

Evaluating REMS Tools: Issues in Survey Design

Louis A. Morris

Therapeutic Innovation & Regulatory Science

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