ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA

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.

Speakers:

Andrew McIntosh, PMP
Project Manager
Office of Generic Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration (FDA)

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