Unhappy With GDUFA II? Note It For GDUFA III, FDA Says
Executive Summary
US agency says it is implementing generic drug user fee program as outlined in commitment letter and any changes should be discussed at negotiations for the 2022 renewal.
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But so far, even broadening the eligibility beyond the GDUFA III commitment has not prompted any generic drug sponsors to request a meeting with FDA staff about issues created by updated or new product-specific guidances. The size of the request package could be one factor.
US FDA Expands Options For Product-Specific Guidance Meetings With ANDA Sponsors
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