CDER SEND Common Issues and Policy Update

Jesse Anderson, Program Manager of CDER’s KickStart Service, discusses common issues seen in sponsor-submitted data and how industry may address these issues. He and colleagues also provide CDER OND policy updates for industry.
Additional speakers include Jennifer Feldmann, an FDA contractor, and Patricia Brundage and Stephanie Leuenroth-Quinn, from CDER’s Office of New Drugs.
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