FDA releases video series for industry that explains new features in the reauthorized GDUFA
Today, the U.S. Food and Drug Administration (FDA) released a series of brief video presentations for industry explaining new features of the Generic Drug User Fee Amendments (GDUFA).
GDUFA was reauthorized and signed into law by the President and will remain in effect from October 1, 2017 through September 30, 2022. The goals and commitments FDA and industry agreed to in the reauthorization of GDUFA promote two major Agency objectives: reducing the time it takes to approve generic drug applications and increasing the number of approved generic drugs.
These videos give an overview of topics including the new avenues of communications that are possible between generic drug applicants and the Agency, especially for the review of complex generic products; and the shorter review goals available for applications that are public health priorities, among others.
In each video, experts provide an overview of the feature, how industry can assist in the process, Agency contact information, resources and more.
For more information and to view the videos please visit: https://www.fda.gov/
ForIndustry/UserFees/ GenericDrugUserFees/ucm580458. htm .