When Do I Need an IND?

November 29, 2023 - 5:00 PM to 7:00 PM

Melatonin, pickle juice, caffeine, and potato starch – what do these items have in common? They were all evaluated by the MICHR IND/IDE Investigator Assistance Program for possible submission to the FDA as a study drug. From probiotics and botanicals to cosmetics and dietary supplements may be considered an investigational drug in which you will need an IND from the FDA.
The Clinical Trials Support Office and the MICHR MIAP Team are hosting a “When do I need an IND?” webinar on November 29 from 5:00 - 7:00 PM. Attendees will learn what factors dictate when they need an IND vs. when an exemption will be granted. Through presentations and a panel discussion, attendees will walk away with an understanding of the full range of investigational “drugs” and the U-M support units that will help you navigate the regulatory and procurement processes.
Presenters and Panelists:

  • Jeanne Wright, Clinical Research Program Director, MIAP
  • Andrew Smith, PharmD, Research Pharmacy
  • Elliot Tapper, MD, Associate Professor of Internal Medicine, Gastroenterology and Hepatology
  • Leslie Swanson, PhD, Clinical Associate Professor, Department of Psychiatry
  • Jeffery Berinstein, MD, Clinical Instructor, Department of Internal Medicine, Gastroenterology