Publications

Publications

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Journal Article

Prospect of Direct Benefit in Pediatric Trials: Practical Challenges and Potential Solutions

Melanie Bhatnagar, Sarah Sheehan, Isha Sharma, Gerri Baer, Dionna Green, Susan McCune, Steven Joffe, and Donna Snyder

Pediatrics, 2021

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Project Report

Characterizing the FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle

Nicholas R. Harrison and Sarah Sheehan

2020

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White Paper

Trust, But Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software

Christina Silcox, Isha Sharma, & Arti Rai.

2020

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Journal Article

FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes

Matthew Rosenberg, Sarah Sheehan, Esther Zhou, Ellen Pinnow, Jessica Burnell, Morgan Romine, Gerald Dal Pan

2020

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