RESOURCES
Coalition Resources
FDA Resources
GDUFA III Commitment Letter
A goals letter was submitted by the FDA containing the performance goals and program enhancements for the GDUFA reauthorization for fiscal years 2023-2027, and can be found here.
GDUFA III Overview
The Generic Drug User Fee Amendment (GDUFA) is designed to speed access to safe and effective generic drugs. More information on stakeholder meetings and the legislative process can be found here.
Generic Drugs Overview
The FDA’s Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures high-quality, affordable generic drugs are made available. More FDA resources on approvals, research, and patient education can be found here.
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Relevant Links
U.S. Government Accountability Office Report: FDA Should Take Additional Steps to Address Factors that may Affect Approval Rates in the First Review Cycle
The U.S. Government Accountability Office produced a report detailing recommendations to the FDA regarding issues in the approval of generic drug applications in the first review cycle, which can be found here.
Increasing Transparency in Generic Drug Applications Act
The Increasing Transparency in Generic Drug Applications Act of 2022 was introduced by Representative Ann McLane Kuster, and the bill text can be found here.
Modernizing Therapeutic Equivalence Rating Determination Act
The Modernizing Therapeutic Equivalence Rating Determination Act was introduced by Senator Bill Cassidy and Senator Tina Smith, and the bill text can be found here.
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