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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
Read MoreComment Letter
CMS Comment Letter on Proposed Coverage Pathway
Mark McClellan, Beena Bhuiyan Khan, Marianne Hamilton Lopez
2021
Read MoreComment Letter
Health Innovation Caucus Comment Letter on Request for Information
Mark McClellan, Marta Wosinska, Nitzan Arad, Rachel Roiland, Alec Lintz, Marianne Hamilton Lopez, Robert S. Saunders
2021
Read MoreProject 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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