Understanding GDUFDA

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Representatives of the U.S. Food & Drug Administration have not minced words when talking about the effect of the Generic Drug User Fee Amendments (GDUFA). The law that established user fees in exchange for a more predictable review process has been called a “transformational change” on more than one occasion.

The transformation is causing growing pains as the Agency chases higher quality Abbreviated New Drug Applications (ANDAs) and industry seeks clarity. For its part, the FDA has been proactive in promoting transparency, twice opening lines of communication to participants in the generic drug industry this calendar year.

A Public Docket was established on January 23 soliciting comment from industry on improving the quality of ANDA submissions, essentially asking what issues are you encountering and how can we be of assistance. Secondly, the Office of Generic Drugs (OGD) undertook unprecedented action when it signaled it would update all applicants on the status of their ANDAs – an activity outside the scope of GDUFA.

This spring there are two additional opportunities for industry and the FDA to collaborate on the numerous priorities outlined in GDUFA.

The first is the 2014 GDUFA and You Conference scheduled for March 27-28 in Lake Buena Vista, FL. The conference is free to attend and will feature a keynote address by the OGD Acting Director Kathleen Uhl, M.D. Highlighted topics include:

  • An overview of the draft guidance for industry: ANDA Submissions – Refuse-to-Receive Standards
  • Communications between FDA and Industry
  • GDUFA Review Efficiency Enhancements
  • A Filing Reviewer’s Perspective on Electronically Submitted Documents

On May 16, the FDA will conduct a public meeting to determine its regulatory science initiatives for generic drugs in FY2015 in Silver Spring, MD. The Agency has indicated a particular interest on receiving input for the following topics:

  • Current regulatory science challenges that limit the availability of generic drugs
  • Regulatory science approaches to improve the preapproval evaluation of therapeutic equivalence of generic drugs
  • Post-approval regulatory science approaches to ensure the therapeutic equivalence of approved generic drugs
  • Prioritization of FY 2015 regulatory science research topics for generic drugs based on public health impact
  • The need for additional or revised draft guidance to clarify FDA’s scientific recommendations related to generic drug development

Considering the current climate of uncertainty surrounding the generic industry, these events are accurately labeled as “must attend.”

Author: GS

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