Same medicine. Same results.
Lower cost.
  • What is GDUFA?

    _

    GDUFA is a historic achievement for both FDA and the generic pharmaceutical industry. GPhA and its members share and fully support GDUFA objectives with 100 percent industry generated funds.

    _

    The three major goals of GDUFA are:

    _

    Safety. Ensure that foreign or domestic companies who participate in the U.S. generic drug system are held to consistent high-quality standards with biennial inspections.

    _

    Access. Speed the availability of low cost, high quality generic drugs by bringing greater predictability and timeliness to the review times for ANDAs.

    _

    Transparency. Enhance FDA’s ability to protect Americans in the complex global supply environment by requiring the identification and registration of all facilities involved in manufacturing of generics and their active ingredients.

    _

    Please explore these resources to learn more about the collaborative effort by the FDA and the generic industry. Together, we will continue working to provide timely access to safe, more affordable generic medicines.

    _