RC2029 Overview of FDA-regulated Research
Learn the basics of FDA-regulated research in this webinar hosted by UT HRPP Regulatory Support. This course is intended for faculty, staff, and students whose human research involves devices, drugs, biologics, or associated products that may be regulated by FDA (e.g. supplements, therapeutic software, diagnostic assays). This high-level overview will introduce investigators to requirements for research with medical devices and drugs. Topics include identifying when a study is subject to FDA jurisdiction, regulatory categories for investigational drugs and devices, and special considerations for consent and IRB review.
Stay informed! You might be surprised by what falls under FDA regulations!
Search course ID RC2029 in Research TRACKS to register.