FDA guidance for industry on ANDA submissions

The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.”

This guidance describes how the assessment goals under the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the FDA. This guidance also details amendment classifications and explains how amendment submissions may affect an application’s assessment goal dates.

The FDA considers each submission to an application under assessment to be an amendment. These submissions will be classified based on the content submitted and issued a goal date consistent with that classification, in addition to other considerations in the GDUFA III Commitment Letter. The types of amendments and assessment goals described in this guidance only apply to submissions that have been received for substantive assessment.