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October 3, 2022

GDUFA III Reauthorization

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality […]
October 3, 2022

GDUFA II Drug Master Files (DMFs)

What’s New GDUFA III enhancements for Type II API DMFs start on 10/1/2022 Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed […]
October 3, 2022

Rare Disease Endpoint Advancement Pilot Program Frequently Asked Questions

Q: What is the Rare Disease Endpoint Advancement (RDEA) pilot program? A: The RDEA Pilot Program is a U.S. Food and Drug Administration pilot meeting program, […]
October 3, 2022

GDUFA III User Fee Resource Management Program

To promote accountability and transparency, GDUFA III includes provisions so that industry and public stakeholders are able to observe how the Agency’s fee revenues are being utilized.  Financial Reports   […]
October 3, 2022

GDUFA III Drug Master File (DMF) Review Enhancements

Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals. The reauthorization of the […]
October 3, 2022

GDUFA III Changes for Facilities

FDA has completed several commitments under the terms of the Generic Drug User Fee Amendments of 2017 (GDUFA II) commitment letter to provide greater transparency regarding […]
October 3, 2022

GDUFA III Controlled Correspondence Enhancements

Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element […]
October 3, 2022

ANDA Assessment Program – GDUFA III Performance Goals and Program Enhancements

GDUFA III includes several enhancements to the abbreviated new drug application (ANDA) assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements […]
October 3, 2022

GDUFA III Enhancements to the Pre-ANDA Program

The Pre-Abbreviated New Drug Application (Pre-ANDA) Program is designed to assist prospective generic drug applicants in developing more complete submissions, promote a more efficient and effective […]
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