The plenary will take a closer look at the impact of user fee legislation, how the FDA advances programs through user fees support, and highlights of some of the exciting new efforts planned during this user fee cycle.
The drugs track will continue its focus on PDUFA VII commitments. Subject matter experts will provide cutting edge insights and perspectives on how several of these goals and initiatives are being implemented. Agenda topics will provide practical information and advances in bioinformatics (eCTD v4.0; ESG; data standards); digital health technologies, real-world evidence (RWE) & pilot programs.
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