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First published 2010-5

FDAAA: Unintended Consequences

Barbara J. Godlew

Therapeutic Innovation & Regulatory Science

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First published 2011-5

FDAAA Basic Results Reporting: First Experience and Challenges

Hans-Theo Forst, Robert Paarlberg, Elizabeth Roberts

Therapeutic Innovation & Regulatory Science

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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 2016-4

An Empirical Examination of the FDAAA-Mandated Toll-Free Statement for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements

Kathryn J. Aikin, Amie C. O'Donoghue, Claudia M. Squire [...]

Journal of Public Policy & Marketing

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Research article

First published 2010-2

Paediatric device development

Linda C. Ulrich

Pharmaceuticals Policy and Law

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First published 2009-11

Evaluating REMS Tools: Issues in Survey Design

Louis A. Morris

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-3

Who Said It Better? A Test of Wording Differences in the MedWatch “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements

Kathryn J. Aikin, Amie C. O’Donoghue, Helen W. Sullivan [...]

Therapeutic Innovation & Regulatory Science

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First published 2010-5

Operational Issues in Clinical Trial Disclosure of Global Trials

Shown M. Pelletier, Maureen A. Strange, Barbara J. Godlew

Therapeutic Innovation & Regulatory Science

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First published 2010-5

ClinicalTrials.gov: A Questionnaire of Industry Experiences and Perceptions

Katie McCarthy, Barbara J. Godlew

Therapeutic Innovation & Regulatory Science

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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

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