US GPhA member support for GDUFA promise and progress

The US Food and Drug Administration’ Office of Generic Drugs acting director Kathleen Uhl, highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act (GDUFA) milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place in Orlando, Florida, on February 20.

The Generic Pharmaceutical Association (GPhA) also the same day launched a new digital library and on-line educational resource, www.GDUFAnow.org, a new tool to enhance awareness and ease industry familiarity with GDUFA responsibilities.

“GDUFA is a historic achievement and shared commitment for the FDA and our industry,” said Ralph Neas, president and chief executive of the GPhA, adding “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 on-line resource highlights regulatory developments, compliance requirements and more - putting all of the critical information in one easy to find location.”