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  1. Generic Drug User Fee Amendments

ANDA Review Enhancements

GDUFA II includes a number of elements to enhance communication between FDA and industry throughout the ANDA review process, thereby improving predictability and transparency and promoting the efficiency and effectiveness of the review process.  Among other provisions, the GDUFA II framework provides for earlier determinations regarding the receipt of ANDAs, enhancements to the process for information requests (IRs), use of discipline review letters (DRLs), timing for notification of communication of review classifications, and establishment of a dispute resolution process.  The GDUFA II commitment letter provides additional information about the ANDA review enhancements.

As part of the GDUFA II commitments, FDA issued a manual of policies and procedures (MAPP) on Communicating Certain Deficiencies Identified During Filing Review of ANDAs.

The following videos explain important elements in GDUFA II regarding ANDA reviews. 

Review Status Updates

This presentation describes the process for requesting and receiving status updates through the ANDA review process in GDUFA II.

 

Transcript | Slides (PDF - 309KB)

 

Post Complete Response Letter Meetings

This presentation outlines the step-by-step process for a successful Post Complete Response meeting request.

 

Transcript | Slides (PDF - 109KB)

 

Requests for Reconsideration

This video describes what is new and what has changed in GDUFA II for Requests for Reconsideration.

 

Transcript | Slides (PDF - 128KB)