Publications

Publications

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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White Paper

Modernizing Medicare Risk Adjustment and Performance Measurement

Mark McClellan, Sara Debab, Frank McStay, Mark Japinga, and Rob Saunders

2024

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Issue Brief

Considerations for FDA’s New Advanced Pharmaceutical Manufacturing Programs

Stephen Colvill, Cameron Joyce, Thomas Roades, Gerrit Hamre

2024

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