Topics in Pharmaceutical Regulation

Monday, June 13, 2016: 10:15 AM-11:45 AM
G17 (Claudia Cohen Hall)
Kathleen L. Miller

This session will explore multiple topics on the subject of pharmaceutical regulation. One paper will discuss the relationship between expedited approval programs and post-market safety events. A second paper will use FDA designations to construct an index to measure pharmaceutical innovation. The final paper presents a case for the efficacy standard in FDA approvals.

10:15 AM
Creating a Conceptual Framework and Index to Measure Pharmaceutical Innovation

Author(s): Kathleen L. Miller

Discussant: Ariel Dora Stern

10:35 AM
The Relationship Between FDA Expedited Programs and Post-Market Safety

Author(s): Andreas Schick

Discussant: Ernst Berndt

10:55 AM
The Political Demand for FDA's New Drug Approval Process: A Reply to Peltzman

Author(s): Peter Vardon; Aliya Sassi

Discussant: Clark Nardinelli

See more of: Prescription Drugs