GDUFA

SOP’s Polli Testifies for GDUFA Renewal at National Public Meeting

August 6, 2015

Testimony examined the impact of FDA-supported research in generic drugs and advocated for continued funding through renewal of the Generic Drug User Fee Amendments of 2012 (GDUFA).

SOP Faculty Testify During FDA Generic Drug Regulation Public Meeting

July 3, 2013

Drs. Hoag and Polli examine current regulatory science initiatives aimed at generic drugs and discuss ways in which existing initiatives can be improved.