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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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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