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Evaluation

2025 PRIM&R Annual Conference

Foundations of Research Ethics and Oversight

Regulatory Frameworks and Compliance

IRB Operations and Management

C02 - FDA Oversight Made Simple: Key Concepts and Application to Research

Friday, November 7, 2025
3:30 PM - 4:45 PM ET
Human Subject Research - HSR Learning Lab Series Call for Session Proposal - CSP
IRBs play a crucial role in reviewing and approving investigational products while ensuring investigators adhere to all relevant regulations. However, navigating FDA regulations related to investigational products can often feel overwhelming and complex for IRB/HRPP staff, members, and researchers alike. This session will introduce key FDA terminology and clarify the decision pathways for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). Participants will also learn about the specific IRB responsibilities associated with each review pathway.

Learning Objectives:

  • Review the fundamental FDA regulatory requirements for devices and drugs
  • Explore the regulatory pathways for medical devices and drugs, with attention to critical considerations for each option
  • Practice applying regulatory concepts through case studies, followed by an interactive Q&A