OHRD Catalog

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OTM Catalog

Research Forum: Drugs & Devices in Research: An Introduction to Navigate FDA Oversight Requirements (back)

Description:
The FDA is responsible for overseeing the use of drugs and devices in clinical investigations, but what does that actually mean? Does it matter that you are not evaluating the safety or effectiveness of the drug or device used in a research study? How does the use of an approved drug or device differ from the use of an investigational product?

Gain an understanding of how FDA drug and device requirements apply to research activities including:
- An overview of the FDA’s drug and device regulations;
- Guidance on identifying what regulations apply to your research activities;
- Information on the practical effects of conducting “FDA Regulated” research;
- Tips to ensure compliance in all FDA Regulated research.

Contact Info:
Rochelle Rannow (rochelle.rannow@wisc.edu)

Intended Audience:
UW-Madison Employees, Students and UW Health employees.

Official Course Website

Tags:
Career Development

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