Topics in Pharmaceutical Regulation

Monday, June 13, 2016: 10:15 AM-11:45 AM
G17 (Claudia Cohen Hall)
Chair:
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