BRIEF—FDA posts two new quarterly reports on generic drugs program performance

The US Food and Drug Administration yesterday posted new quarterly activity metrics for the Generic Drugs Program.

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems.

The agency committed to reporting these metrics in section VI(C)(2) of the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements for Fiscal Years 2018-2022 (GDUFA II Commitment Letter).

The new quarterly report focuses on the number of Abbreviated New Drug Applications (ANDAs) awaiting applicant action, the number of ANDAs awaiting FDA action, and the mean/median time to tentative or final approval.

The new reporting complements the ongoing monthly and annual reporting that are part of Enhanced Accountability and Reporting under GDUFA II.

In addition, on February 14, 2018, the agency published the first Quarterly Report of the Generic Drugs Program as required in section 807 of the FDA Reauthorization Act of 2017 (FDARA).

The report provides statistics on certain ANDAs subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy designation under section 506H of the FD&C Act.