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This meeting is for internal users only.
IRBMED Course: Basics of FDA Regulated Research: Human Subjects Research Involving Drugs and Devices (Level III)
This course will provide and introduction to the FDA requirements for conducting research with a drug or medical device, including conducting research under an IND (Investigational New Drug Application) and an IDE (Investigational Device Exemption). This course will also include an introductory discussion on the FDA's Expanded Access Program which provides a pathway for patients to gain access to investigational drugs, bioloigcs and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.

Dec 1, 2020 10:00 AM in Eastern Time (US and Canada)

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