FDA’s New Regulatory Framework for Tobacco and Nicotine: the Role of Medicinal Nicotine December 12, 2017 - 12:30 pm National Press Club 529 14th Street NW Washington, DC 20045 The U.S. Food and Drug Administration (FDA) recently announced a new, comprehensive regulatory...
Advancing Structured Benefit-Risk Assessment in FDA Review October 4, 2017 (All day) The Duke-Margolis Center for Health Policy 1201 Pennsylvania Avenue, NW, 5th Floor, Washington, DC 20004 As part of a broader effort to increase the predictability, transparency, and efficiency of its...
Exploring Approaches for Value-based Reimbursement of Oncology Therapies October 3, 2017 (All day) Duke-Margolis Center for Health Policy 1201 Pennsylvania Avenue NW, Suite 500 Washington, DC. 20004 Advances in cancer care have resulted in significant improvement in patient outcomes, but... Biomedical InnovationHealthcare Transformation
Public Event: Mobilizing mHealth Innovation for Real-World Evidence Generation September 15, 2017 - 2:00 pm to 4:00 pm Duke-Margolis Center for Health Policy Ground Floor Conference Room 1201 Pennsylvania Avenue, NW Washington, DC 20004 Webcast available, please register through the link above. As consumers embrace new technologies as part of their... Biomedical Innovation
Public Workshop: A Framework for Regulatory Use of Real-World Evidence September 13, 2017 - 9:00 am to 4:00 pm 1777 F Street Conference Center 1777 F Street NW Washington, DC 20006 The Duke-Margolis Center would like to continue to solicit feedback on the white paper and its...
Public Webinar: Keeping Up with Consumers: How can mHealth apps and wearables help evaluate medical products? June 26, 2017 - 2:00 pm to 4:00 pm The Duke-Margolis Center is working to advance the development of new sources of data for the...
Exploring Outcomes and Value across the Spectrum of Alzheimer’s Disease June 20, 2017 (All day) Duke-Margolis Center for Health Policy 1201 Pennsylvania Avenue, NW, 5th Floor, Washington, DC 20004 Alzheimer’s disease is devastating for both patients and their families. As the population ages... Healthcare TransformationBiomedical Innovation
Public Workshop: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices June 14, 2017 (All day) to June 15, 2017 (All day) Duke-Margolis Center for Health Policy 1201 Pennsylvania Avenue, NW, Washington, DC Over the last several years, FDA as well as others in the scientific community have co-sponsored...
Building a National Resource for Evidence Generation: Exploring How Sentinel Infrastructure Could Generate Real-World Evidence on PCSK9 Inhibitors June 8, 2017 (All day) to June 9, 2017 (All day) Duke-Margolis Center for Health Policy 1201 Pennsylvania Avenue NW Washington, DC 20004 The Robert J. Margolis Center for Health Policy at Duke University, under a cooperative...
International Harmonization of Expedited Programs: Challenges and Opportunities for Increasing Patient Access to Innovative Therapies June 7, 2017 (All day) Duke-Margolis Center for Health Policy Regulatory agencies across the world, including the U.S. Food and Drug Administration (FDA), the...
