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FDA's Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles
Howard Chazin1,2, Jason Woo3, Jing Han4
1U.S. Food and Drug Administration, Office of Generic Drugs, Silver Spring, MD, USA. howard.chazin@fda.hhs.gov.
Therapeutic Innovation & Regulatory Science
|June 20, 2020
Summary
The Generic Drug User Fee Amendments (GDUFA I) successfully modernized the FDA
Area of Science:
- Pharmaceutical policy
- Drug regulation
- Regulatory science
Background:
- The Food and Drug Administration Safety and Innovation Act of 2012 introduced the Generic Drug User Fee Amendments (GDUFA I).
- GDUFA I aimed to modernize the U.S. Food and Drug Administration's (FDA) review process for Abbreviated New Drug Applications (ANDAs).
Purpose of the Study:
- To evaluate the effectiveness of GDUFA I in reducing the time to approval for ANDAs.
- To assess the impact of GDUFA I on the number of review cycles for ANDAs.
Main Methods:
- Analysis of ANDA review data over the five fiscal years of GDUFA I.
- Quantitative assessment of time to approval and review cycle counts.
Main Results:
- GDUFA I implementation led to modernization of the ANDA review process.
- The study indicates progress in the FDA's generic drug program.
- Collaborative communication between the FDA and ANDA applicants is crucial.
Conclusions:
- GDUFA I has been successful in streamlining the generic drug approval process.
- Continued collaboration is essential for the timely delivery of safe and effective generic drugs.
- The FDA's generic drug program shows continuous improvement.
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