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Drug Information Association and Food & Drug Law Institute Collaborate in Conference to Examine FDA User Fees

8/30/2012 11:02:09 AM

HORSHAM, PA, USA—AUGUST 30, 2012— DIA, the premier organization 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 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 programs 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. Prior to joining the Agency, Ms. Ireland served as chief public health advisor to former chairman John D. Dingell on the House Energy and Commerce Committee, where she oversaw legislative efforts to regulate tobacco, improve the safety of the food supply, and increase oversight of imported drugs and medical devices. Shuren serves as Director of the Agency’s Center for Devices and Radiological Health (CDRH) and has held many FDA policy positions including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning and medical officer in the Office of Policy. He will discuss how FDASIA affects the medical device center’s work.

“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.

Register for Unwrapping FDA’s 2012 UFA Package: What’s Inside the Statute, What’s Next? Presented by DIA and FDLI here.


DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. Follow DIA on Facebook, Twitter, LinkedIn, and YouTube. Stay updated on hot topic news at #druginfoassn on Twitter.


The Food and Drug Law Institute, was founded in 1949 and provides training, promotes networking, and ensures an open, balanced dialogue. As a non-profit organization with more than 700 corporate and individual members, FDLI has the unique advantage of bringing the food and drug law community together with regulators (such as FDA staff) along with the private bar and regulated industry. Convening this community allows FDLI to offer educational opportunities to food and drug law professionals. The scope of FDLI includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. FDLI is a not-for-profit 501(c)(3) organization. Follow FDLI on Twitter, LinkedIn, and Flickr.

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