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Regulatory Focus™ > News Articles > 3 > New FDA Generic Drug Reports Tabulate Approval Times

New FDA Generic Drug Reports Tabulate Approval Times

Posted 14 March 2018 | By Zachary Brennan 

New FDA Generic Drug Reports Tabulate Approval Times

Thanks to the second iteration of the Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) for the first time ever began publishing quarterly metric reports on approval and tentative approval times.

The new quarterly performance report released Wednesday – unlike the updated monthly activities report, which lists approvals, complete responses and dozens of other statistics, or the generic drug dashboards, which detail the abbreviated new drug application (ANDA) workload – offers statistics on ANDAs awaiting FDA or applicant action, as well as mean and median approval times.

According to the first dashboard, the mean approval time (calculated as the difference between the first full approval date and the date the original application was accepted for filing, divided by the average number of days per month [30.4375]), from Q1 2018 was 41.7 months, while the median approval time was 41.88 months.
Tentative mean and median approval times were about 10 months less than the full approvals.

The new reporting complements ongoing monthly and annual reporting that are part of what FDA calls “Enhanced Accountability and Reporting” under GDUFA II.

In addition, on 14 February, the agency published the first Quarterly Report of the Generic Drugs Program as required by the FDA Reauthorization Act of 2017. This quarterly report provides statistics on certain ANDAs subject to priority review and certain ANDAs with a competitive generic therapy designation under section 506H of the Food, Drugs & Cosmetics Act.

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