Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities June 12, 2019 - 9:00 am to 4:00 pm Tommy Douglas Conference Center 10000 New Hampshire Avenue Silver Spring, MD, 20903 To support the efficient review of medical products, the U.S. Food and Drug Administration (FDA...
Public Meeting: Characterizing FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle May 16, 2019 - 9:00 am Tommy Douglas Conference Center 10000 New Hampshire Avenue Silver Spring, MD 20903 Following the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), the U.S....
Eleventh Annual Sentinel Initiative Public Workshop April 3, 2019 - 9:00 am to 4:30 pm Hyatt Regency Bethesda 1 Bethesda Metro Center Bethesda, MD 20814 The Sentinel Initiative was launched in response to the Food and Drug Administration Amendments...
Healthcare Costs Innovation Summit April 2, 2019 - 9:00 am to 3:00 pm AMPHITHEATER AT RONALD REAGAN BUILDING AND INTERNATIONAL TRADE CENTER 1300 PENNSYLVANIA AVENUE, NW WASHINGTON, DC 20004 West Health’s High Costs, Broken Promises: Healthcare in America Summit (HCI Summit) on April...
Aligning Access with Outcomes for Early-Stage Alzheimer’s Disease Drugs February 25, 2019 - 9:00 am Duke-Margolis Center for Health Policy, Washington, DC A number of innovative “early stage” Alzheimer’s disease (AD) therapies are currently under...
Advancing Health Care Transformation in North Carolina February 8, 2019 - 9:00 am to 3:00 pm Washington Duke Inn 3001 Cameron Boulevard Durham, NC 27705 On February 8, 2019, the Duke-Margolis Center for Health Policy will bring together stakeholders...
Evaluating the Pressor Effects of Drugs & Ambulatory Blood Pressure Monitoring Studies February 4, 2019 - 9:00 am to 4:30 pm 1777 F Street NW Washington, DC 20006 The U.S. Food and Drug Administration (FDA) is announcing a public workshop entitled “Evaluating...
Developing Feasible Payment Reform Pathways for Antibiotics to Meet the Needs of Providers, Payers, and the Populations They Serve January 29, 2019 - 9:00 am Duke-Margolis Center for Health Policy, Washington, DC Serious bacterial infections can result in costly hospital stays and complications, particularly...
Unpacking Real-World Data Curation: Principles and Best Practices to Support Transparency and Quality January 22, 2019 - 9:00 am to 4:00 pm Duke-Margolis Health Policy Center 1201 Pennsylvania Ave NW, 5th Floor Washington, DC 20004 In the coming years, there will be emerging opportunities for making better use of real-world...
Implementation of Signal Detection Capabilities in the Sentinel System December 3, 2018 - 9:00 am to 4:30 pm Hyatt Regency Bethesda Regency Ballroom One Bethesda Metro Center Bethesda, Maryland, 20814 On December 3, 2018, in cooperative agreement with the U.S. Food and Drug Administration (FDA),...
