Clinical Data Transparency

By Janet Woodcock, MD, Director, CDER, FDA; Anne M. Rowzee, PhD, Lead Writer/Editor, Division of Online Communications, FDA

Many developments have brought clinical trial data transparency to the forefront of our stakeholders’ minds – from the expanding...

Breakthrough Therapy Designation Bringing Innovation Swiftly to Patients

By Arpita Shah, PharmD, RPh; Regulatory Affairs, Celgene Corporation

In early 2012, the Breakthrough Therapy Act was introduced into the US House of Representatives and the Senate...

Budget, Funding and HTA Updates from Canada

By Judith Glennie, PharmD; President, J.L. Glennie Consulting, Inc., Canada

Outside of its regulatory responsibilities, the federal government’s role in the Canadian health system tends to be limited...

Advancing the Science of Study Endpoints: Seeking Practical Solutions

Hyatt Regency Bethesda