FDA guidance on ANDA submissions

With the US Generic Drug User Fee Amendments (GDUFA) reauthorized by Congress on September 30, 2022, known as GDUFA III, these provisions are in effect October 1, 2022, through September 30, 2027.

The US Food and Drug Administration (FDA) said on Friday that it is committed to ensuring current and prospective abbreviated new drug application (ANDA) applicants have the information they need to successfully submit high-quality ANDAs throughout the GDUFA III cycle.

As a result, on October 14, 2022, the FDA published the revised final guidance ANDA Submissions – Prior Approval Supplements Under GDUFA. This guidance, previously published in October 2017, is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for ANDAs.