Investigator-Initiated Investigational New Drug (IND) Applications

Tuesday, August 25, 2026 from 11:00 AM to 12:00 PM

Join the FDA Support Team from the UH Research Support Core for an overview of how to submit and maintain Investigational New Drug (IND) applications to the FDA as a sponsor-investigator.

Join the FDA Support Team from the UH Research Support Core for an overview of how to submit and maintain Investigational New Drug (IND) applications to the FDA as a sponsor-investigator. 

After this session, participants will be able to: 

• Define the roles of a sponsor-investigator when conducting a study of an Investigational New Drug (IND).
• Explain when an IND is required.
• List the steps for submitting an IND to the FDA.
• Identify Institutional resources that support sponsor-investigators.
• Explain key FDA regulatory requirements for maintaining an IND, including safety reporting and protocol amendments.

Presenter: Anthony Dick, MD, MPH, ACRP-CP

HRP Competency: Regulatory Overview (Pending)

Register via UH GPS