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Journal Article
Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities
An N. Massaro, MD, Beth Boyer, MPH, Mira Gill, MS, Dure Kim, PharmD, Matthew Laughon, MD, MPH, Michele Walsh, MD, Monica E. Lemmon, MD, Betsy Pilon, BA, and Gerri Baer, MD, on behalf of the Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants*
2024
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Considerations for FDA’s New Advanced Pharmaceutical Manufacturing Programs
Stephen Colvill, Cameron Joyce, Thomas Roades, Gerrit Hamre
2024
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Reforms Needed to Modernize the US Food and Drug Administration’s Oversight of Dietary Supplements, Cosmetics, and Diagnostic Tests
Scott Gottlieb, MD and Mark B. McClellan, MD, PhD
2022
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America needs a confirmed leader at FDA — now
Mark McClellan, Scott Gottlieb, and Margaret Hamburg and Andy Slavitt
2022
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