Rx REPORT

FDA Issues Draft Guidance on ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA

On October 3, 2017, FDA issued draft guidance to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).  This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates.  The guidance also describes how FDA should review amendments submitted to ANDAs and PASs received prior to October 1, 2017, which is the GDUFA II review goals effective date.

When final, this guidance will replace the December 2001 guidance for industry Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (2001 amendments guidance).  This draft guidance supersedes the July 2014 draft guidance for industry ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA.

FDA is accepting comments on this draft guidance through December 4, 2017.

Click to Open Official Publication