Mar 30, 2023  
2018-2019 Undergraduate Catalog 
2018-2019 Undergraduate Catalog [Archived Catalog]

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BME 450 - Regulatory Pathways for Medical Product Development

The Food and Drug Administration has developed several pathways such as Fast Track, Breakthrough Therapy, and Accelerated Approval that can be used to more efficiently move a drug or device through the approval process.  This course will explore the different pathways and how the FDA determines which products can use these alternative regulatory pathways to move medical products from discovery to market. Prerequisite: ISCI 353 .

3 cr

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