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M. Dianne Murphy

Food and Drug Administration

18

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976

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A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007-2013

2016 Therapeutic Innovation & Regulatory Science
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Impact of Pediatric Exclusivity on Drug Labeling and Demonstrations of Efficacy

2014 Pediatrics
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The Globalization of Pediatric Clinical Trials

2012 Pediatrics
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Pediatric information in drug product labeling.

2012 JAMA
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Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs

2011 Pediatrics
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Globalization Facilitates Pediatric Drug Development in the 21 st Century

2010 Drug Information Journal
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Safety and Transparency of Pediatric Drug Trials

2009 JAMA Pediatrics
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Safety of Placebo Controls in Pediatric Hypertension Trials

2008 Hypertension
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Pediatric Antihypertensive Trial Failures. Analysis of End Points and Dose Range

2008 Hypertension
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The economic returns of pediatric clinical trials of antihypertensive drugs.

2008 American Heart Journal
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Citations (26)