Improving FDA Approval Standards through Better Information and Evidence Generation
The Clinical Evidence and Communication unit aims to provide objective and measurable assessments of the clinical evidence for novel therapeutics in the premarket and postmarket phases, linking these outputs to specific policies that influence regulatory activities. The overarching goal is to drive more robust evidence generation for drug approvals through enhanced communication about drug benefits and increased quality and compliance with FDA-mandated studies in the postmarket phase. This work is generously supported by the Laura and John Arnold Foundation.
The interdisciplinary research studies are conducted through partnerships with the Department of Population Medicine, Division of Health Policy and Insurance Research at Harvard Medical School, the Department of Health Policy at the London School of Economics, and the Dartmouth Institute for Health Policy and Clinical Practice. The program is led by Dr. Florence Bourgeois in collaboration with Drs. Anita K. Wagner and Huseyin Naci.
EVENTS
Communicating Information about Benefits and Harms of New Drugs
The HMCRS Clinical Evidence and Communication Unit is partnering with (list partners here) on a project funded by Arnold Ventures, to enhance the communication of regulated information about new drugs in the United States. Our workshop will convene industry experts and academics to…
- Lay out the needs for improved regulated drug information
- Identify priority approaches for improving regulated drug information in the US, also considering approaches underway in Europe
The Workshop will be conducted on April 10th, 2025 in a hybrid format from Harvard Medical School.