Table of Contents
Table of Contents
Preface
The Food and Drug Administration Safety
and Innovation Act (FDASIA, P.L. 112-144)
(Susan Thaul, Erin Bagalman, Amalia K. Corby-Edwards, Judith M. Glassgold, Judith A. Johnson, Sarah A. Lister, Amanda K. Sarata)
Prescription Drug User Fee Act (PDUFA): 2012 Reauthorization as PDUFA V
(Susan Thaul)
The FDA Medical Device User Fee Program
(Judith A. Johnson)
Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA)
(Susan Thaul, Judith A. Johnson)
Index