Patient Engagement in Benefit-Risk Assessment throughout the Life Cycle of Medical Products

Bethesda North Marriott Hotel and Conference Center

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 implementation of electronic health records and electronic data submitting requirements to the new proposed rules from HHS on clinical trial data reporting. This year, OIG plans to review the extent to which clinical trialists comply with FDAAA clinical trial reporting requirements and to assess FDA’s efforts to ensure these requirements are being met.


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. The bills received bipartisan support and were included as an amendment to the Food and Drug Administration Safety and Innovation Act in the Prescription Drug User Fee Act V. On July 9, 2012, the breakthrough therapy designation was signed into law.

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. However, several proposed investments illustrate the government’s attempts to address broad health challenges and/or foster innovation to support the health and life sciences sector. An election-year budget that was tabled in the Canadian Parliament on April 21, 2015, included the below targeted investments in Canada’s health and life sciences sector:

Clinical Trial Disclosure & Data Transparency – The Expanding Global Environment

Hyatt Regency Bethesda

DIA/FDA Oligonucleotide-Based Therapeutic Conference 2015

Grand Hyatt Washington at Washington Center