FDA Oversight of Tobacco Product Investigations - ITP or IND?

March 12, 2019 - 1:00pm to 2:00pm
Stephanie Pierce, PhD, RAC

The Duke Office of Regulatory Affairs and Quality (ORAQ) will be hosting a seminar on FDA oversight of tobacco products and their use in clinical investigations. This will be a one hour, interactive session that will aid investigators and study teams in determining when an investigational tobacco product will require FDA oversight through an ITP or an IND. In addition, this presentation will include details on submitting applications to FDA, and describe how ORAQ can assist Duke investigators with any questions or regulatory needs.