GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors
Executive Summary
Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.
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Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?
New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.
Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?
New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.
US FDA Expands Options For Product-Specific Guidance Meetings With ANDA Sponsors
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.