PHS 7702 - Intersection of Trans & Reg: The FDA & Clinical Science

Effective Start Date: 04/09/2018
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
Grading Basis: Graded