DIA - a global, professional, member-driven association of nearly 18,000 professionals involved in discovery, development, life cycle management of pharma, biotech, medical devices and dedicated to knowledge exchange that fosters innovation to raise the level of health and well-being worldwide, and the Food and Drug Law Institute (FDLI) - a non-profit member-driven organization committed to advancing food and drug law education, are hosting the conference - Unwrapping FDA’s 2012 UFA Package: What’s Inside the Statute, What’s Next?. On September 20 in Washington, DC.

This collaborative effort will focus on the Food and Drug Administration Safety and Innovation Act (FDASIA) which was signed into law by the US president in July 2012. This legislation includes Prescription Drug User Fee Act (PDUFA V), Medical Device User Fees (MDUFA III), Generic Drug User Fee Amendments of 2012 (GDUFA), and Biosimilar User Fee Act (BsUFA). DIA and FDLI are excited to be collaborating on this conference that will discuss future implications and next steps in preparing for 2017 user fee negotiations.

Session topics will include: Highlights of the Prescription Drug User Fee Act (PDUFA V), Medical Device User Fees (MDUFA III), Generic Drug User Fee Amendments of 2012 (GDUFA), and Biosimilar User Fee Act (BsUFA). Premarket issues and components of FDASIA that will affect the medical device review process. Reviewing additional provisions for regulatory science, Enhanced communications and transparency, Enhanced drug development with approval, Access to experts in pediatrics, breakthrough therapies, and Generating Antibiotic Incentives Now (GAIN)/antibacterials

“Congressional reauthorization of FDA’s user fee programmes consistently involves changes to the federal Food, Drug, and Cosmetic Act, as well as changes to performance expectations for the Agency,” said Susan Winckler, President and CEO of FDLI. “This conference will explore the most recent set of changes - identifying what you need to know about the latest legal landscape for FDA regulation of medical products.”

Keynote speakers Jeanne Ireland and Jeffrey E. Shuren will lend their views on the new legislation. Ireland is FDA’s assistant commissioner for legislation and led the FDA’s efforts to move the broad user fee package through Congress. She will open the conference with an overview of the Congressional process as well as what stakeholders should be familiar with in FDASIA.

 “DIA has always been proactive in working with others in meeting the changing needs of our stakeholders around the world. We will continue to expand into new content areas to collaboratively engage industry, regulatory, scientific, and patient communities, to serve the health of patients around the world,” said Paul Pomerantz, worldwide executive director of DIA.