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Evaluation On-Demand Video

2024 PRIM&R Annual Conference

FDA Regulated Research

IRB Review

Pharma/Biotech Perspectives

A03 - Why “It Depends”: General Considerations for IRBs and HRPPs When Reviewing Research Using FDA-Regulated Products

Monday, November 18, 2024
10:30 AM – 11:45 AM PT
Location: Room 431-432
Live Session Recorded Human Subject Research - HSR Deep Dive Series Live Streamed Session CIP Accredited
CLICK HERE to view captioning for this session! 

For IRBs that do not routinely review FDA-regulated research, determining if and how a particular study involving a medical product is “FDA-regulated” can be challenging given Agency regulations and requirements for such research. As often noted by FDA, such determinations depend on multiple factors, so it is not often possible to determine whether a certain type of research is regulated by FDA without considering study specifics. However, there are a series of questions that IRBs and investigators may consider to help them determine whether FDA regulations apply and if FDA consultation is needed. In this session, representatives from the FDA will provide an overview of the regulations and guidances that may be useful to investigators developing and IRBs reviewing research of an FDA-regulated product.

Learning Objectives:

  • Understand the FDA regulations and guidances associated with FDA oversight of clinical research
  • Describe different regulatory considerations that might help facilitate determinations about whether FDA oversight is needed, and provide study examples
  • Identify resources and contacts to engage with FDA about the applicability of FDA regulations for research studies