Sarah DeMare Published in DIA Global Forum Report

VRS’ own Sarah DeMare has two articles published in the June 2015 DIA Global Forum Report.

 

Cut the Cycle, not the Science: Breakthrough Therapy Designation appears on page 98.

Signed into law in July 2012, the US Food and Drug Administration Safety and Innovation Act (FDASIA) included a new expedited drug development pathway known as Breathrough Therapy Designation… Read more here.

The Future of Post-Approval Change Management appears on page 101.

Quality by Design (QbD) was introduced nearly ten years ago as part of the FDA’s 21st century quality initiative… Read more here.