Amendments to Abbreviated New Drug Applications Under GDUFA
The FDA’s Generic Drug User Fee Amendments (GDUFA III) are designed to enhance the review process for ANDAs (Abbreviated New Drug Applications), ensuring faster, more efficient access to affordable medications. Here’s what you need to know:
Purpose:
Provides guidance on how amendments to ANDAs (Abbreviated New Drug Applications) or PASs (Prior Approval Supplements) are classified and assessed under GDUFA III (2022)
Amendment Categories:
- Major Amendments: Require significant changes like new bioequivalence studies or manufacturing changes.
- Minor Amendments: Include responses to simpler deficiencies such as minor labeling or formulation changes.
- Unsolicited Amendments: Submissions not requested by the FDA, but may still impact review timelines.
Assessment Timelines:
- Major amendments generally assessed within 8-10 months.
- Minor amendments assessed within 3 months.
- Priority applications (faster review for critical needs) can shorten the assessment timeline
Preapproval Inspections:
Amendments may require facility inspections which can impact approval timelines, especially for new manufacturing sites or major changes.
Goal of GDUFA III:
Streamline the generic drug approval process to improve access to affordable medications in a timely manner, reducing the number of review cycles.
Requests for Reconsideration:
Applicants can request reclassification of amendment status if they disagree with the FDA’s classification.
Potential Deficiencies:
The document outlines common issues that may classify as major deficiencies, impacting the timeline, such as the need for additional studies or unresolved facility issues.
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