Pharmaceutical & Drug Policy
Comments on GLOBE and GUARD drug pricing models
This event was the first of a new series of roundtable teleconferences on active medical product surveillance – providing a forum to discuss public and private initiatives in which methods, data sources, and technology related to active medical product surveillance are being developed.
The call featured an update from FDA leaders on their active surveillance activities, as well as a moderated question and answer period following the FDA’s presentations.
Convened by the Engelberg Center for Health Care Reform at Brookings and suppored by a grant from the Food and Drug Administration.
Agenda
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October 30
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Welcome and Introduction
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Update on FDA Active Surveillance Efforts
JRJudy Racoosin Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and ResearchJSJudy Staffa Associate Director for Regulatory Research, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDABBBob Ball Medical Officer IV, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDATSTom Scarnecchia Executive Director, Observational Medical Outcomes Partnership, FNIH -
Roundtable Discussion and Questions
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Wrap-Up and Next Steps
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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