Regulatory Affairs Updates: Latest on ANDA User Fees (GDUFA)

FDA and industry leaders have agreed on legislation that, if passed by Congress, will usher in user fees for ANDA sponsors.

As currently drafted, a one-time backlog fee is anticipated for “Each person that owns an abbreviated new drug application (ANDA) that is pending on October 1, 2012, and that has not received a tentative approval prior to that date”.  The draft legislation notes that the backlog fee will be computed by dividing the total number of applicable ANDAs into $50 million.  As of December 2011 the backlog consisted of approximately 2,500 applications, though not all could be considered “applicable”.  Once the backlog fee is calculated, the amount will be announced in the Federal Register.  Click here for help with your ANDA, 505(b)(2) or NDA submission and other FDA consulting needs.   Click on the following links to learn more about GDUFA: