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  4. ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA - 09/10/2024
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Virtual | Virtual

Event Title
ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA
September 10, 2024

Date:
September 10, 2024

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ABOUT THIS EVENT (Hosted by CDER SBIA)

FDA revised the 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 FDA. This guidance also details amendment classifications and explains how amendment submissions may affect an application’s assessment goal dates.

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.

This guidance replaces the July 2018 guidance for industry of the same name. The revisions address comments received to the 2022 public docket requesting input on appendix A of the guidance, which includes a non-exhaustive list of examples of deficiencies that FDA may consider major. FDA considered all comments carefully, and made changes to the guidance language, including clarifying many of the examples listed in appendix A and making other minor edits to reflect GDUFA III commitments.

Comments may be submitted to this (or any FDA) guidance at any time for agency consideration, in accordance with FDA’s good guidance practices. The public docket, which contains background documents and all electronic and written/paper comments received, is available at www.regulations.gov. To view or provide comments to the docket for a guidance, insert the guidance docket number, FDA-2017-D-5670, into the “Search” box. Then click on the most recent version of the published guidance to submit comments.

FDA is publishing this guidance as a GDUFA III deliverable and as part of the Drug Competition Action Plan.

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