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Graduate Record 2019-2020 [ARCHIVED RECORD]
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PHS 7702 - Intersection of Trans & Reg: The FDA & Clinical Science
Provides discussion of forces & events that have shaped the modern FDA & oversight of therapeutics (Drugs, Biologics & Devices), as well as how the FDA shaped clinical science. How science informs FDA & vice-versa to help better understand why FDA regulates the way it does. Case studies to discuss seminal events in FDA’s evolution as well as its modern challenges as science & approaches to disease become increasingly complex.
Credits: 3
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