FDA Solicits Feedback on ANDA Submissions – Amendments to ANDAs Under GDUFA Guidance, Appendix A

August 12, 2022

Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for industry entitled “ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA” (ANDA Amendments Guidance). The agency is soliciting comments on the content of Appendix A to fulfill its commitment described in section IX.B. of the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 Commitment Letter (GDUFA III Commitment Letter).

In the GDUFA III Commitment Letter, FDA agreed to issue a Federal Register notice to solicit public comment on the content of Appendix A in the ANDA Amendments Guidance on or before April 30, 2023. The ANDA Amendments Guidance describes amendment classifications (“major” or “minor” amendments) and categories (amendments subject to “priority” or “standard” review goals) and explains how amendment submission classification and category may affect an amendment’s performance goal date. Appendix A in the ANDA Amendments Guidance is a non-exhaustive list of examples of deficiencies that FDA may consider major.

With this notice, FDA is seeking comments on the examples of major deficiencies listed in Appendix A of the ANDA Amendments Guidance, as well as comments on how any proposed revisions to that list could be beneficial to industry in understanding ANDA amendment classification. For more details, please see the Federal Register notice.

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.

TAGS:

Several pills sitting on a table.

FDA publishes product-specific guidances to facilitate generic drug development

Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...

Navigating FDA User Fee Updates for Fiscal Year 2023

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...

January 21, 2019

FDA Draft Guidance on Tentatively Approved ANDA Submissions

On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22, 2018. The draft guidance, entitled "ANDA Submissions –...