FDA's Regulation of Prescription Drug Safety and Effectiveness

2 Credits.

Reviews regulatory standards and how FDA evaluates epidemiologic evidence to assess a drug’s efficacy and safety. Examines the quality and quantity of epidemiologic evidence needed to demonstrate substantial evidence of effectiveness for a drug and how FDA assesses and balances the drug’s harms and risks based on the relevant evidence. Reviews the accelerated approval pathway as a regulatory option for a drug’s approval, and how FDA applies this pathway based on the epidemiologic evidence. Assesses case studies of FDA actions applying these methods of assessment and standards.