Presented by the Food and Drug Law Institute and the Drug Information Association, this conference provided a first look at the Food and Drug Administration Safety and Innovation Act (FDASIA). Signed into law by the President in July, this legislation includes PDUFA V, MDUFA III, GDUFA and BsUFA.
The content of these UFA packages will shape the timeliness of reviews of life-saving medicines and medical devices, the requirements of all phases of medical product development, and the industry’s ability to innovate and develop needed medical products. Reactor panels will provide the exchange of views on what the UFA provisions will mean for innovation, how they will improve patient access to needed medical products over the next five years, and next steps in preparing for 2017.
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