Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop

The Food and Drug Administration (FDA, the Agency, or we) is announcing the public workshop entitled ``Safety Assessment for IND Safety Reporting.'' Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to ``Safety Assessment for Investigational New Drug (IND) Safety Reporting.'' This public workshop is organized in response to public comments received to Docket No. FDA-2015-D-4562 for the draft guidance ``Safety Assessment for IND Safety Reporting'' issued in December 2015 requesting a public meeting to discuss the draft guidance and its implications. The public workshop is intended to engage external stakeholders in discussions related to finalizing the draft guidance entitled ``Safety Assessment for IND Safety Reporting.''