FDA's Center for Drug Evaluation and Research revised the final guidance last week titled "ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA" which explains how the assessment goals under the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) apply to any amendment submitted to FDA for either abbreviated new drug applications (ANDAs) or prior approval supplements (PAS).
The guidance assists applicants in understanding how to submit amendments for ANDAs and how these submissions are assessed by the FDA. It also highlights the types of amendments classified under GDUFA, clarifying how they impact regulatory review timelines.
The Generic Drug User Fee Amendments (GDUFA) were enacted to improve the efficiency and speed of generic drug approvals. The FDA classifies amendments based on their complexity and potential impact on the review process, which affects the timeline for approval.
Categories of GDUFA Amendments
Amendments to ANDAs fall into three main categories:
A. Major Amendments: These involve significant deficiencies that require substantial review efforts, typically leading to extended review timelines.
B. Minor Amendments: These address less complex issues, and their review usually results in a quicker turnaround.
C. Unsolicited Amendments: These are amendments submitted without prior request from the FDA and may affect the review process.
Each amendment to an application under assessment is considered an amendment by FDA. In addition to other considerations in the GDUFA III Commitment Letter, these submissions will be classified based on their content and assigned a goal date consistent with that classification. This guidance only applies to submissions whose substantive assessment has been scheduled.
The FDA has specific timelines for reviewing amendments to ANDAs. These timelines vary depending on whether the amendment is classified as major, minor, or unsolicited. Proper submission procedures for amendments ensure timely receipt and processing by the FDA.
The Appendix in this guidance lists common issues that could result in a major amendment classification. These include significant gaps in bioequivalence data, clinical study deficiencies, or substantial manufacturing concerns. For more detailed information, visit:
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