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Course ID:PHAR(PMCY) 4010E. 3 hours.
Course Title:Introduction to Drugs, Biologics, and Devices Regulated by the Food and Drug Administration
Course
Description:		Introduction to the drugs, biologics, and devices regulated by the Food and Drug Administration (FDA) and the pharmaceutical, biotechnology, and medical device industries. Organization of the FDA, basic understanding of regulatory framework in the U.S., including regulations and regulatory process, overview of product development, and new product applications process and post- marketing/commercialization compliance expectations.
Athena Title:Drugs Biologics Devices FDA
Nontraditional Format:This course will be taught 95% or more online.
Prerequisite:Permission of department
Grading System:A-F (Traditional)
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