FDA addresses GDUFA at recent GPhA meeting; association launches online GDUFA resource


ORLANDO, Fla. — Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl on Thursday highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

The Generic Pharmaceutical Association also launched a new digital library and online educational resource, GDUFAnow.org, a new tool to enhance awareness and ease industry familiarity with GDUFA responsibilities, on Thursday.

“GDUFA is a historic achievement and shared commitment for the FDA and our industry,” stated Ralph Neas, president and CEO, GPhA. “GDUFA is supported 100% with industry generated funds. Indeed, efforts to ensure safety, increase access to generics and enhance transparency are top priorities for the Association. This new online resource highlights regulatory developments, compliance requirements and more — putting all of the critical information in one easy to find location.”

As FDA Commissioner Hamburg relayed from India in a recent FDA Voice post: “FDA is working quickly to fulfill one of our commitments under [GDUFA] — reducing the backlog of generic drug applications. As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45% of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs. GDUFA also requires that we step up our number of foreign inspections and gives us the funding to do so.”



This ad will auto-close in 10 seconds