Regulatory Pathways for Medical Product Development

Catalog description

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. Prerequisites and Corequisites Prerequisite: ISCI 353