Stakeholders Offer Some Hatch-Waxman Creativity, Highlight Limits Of FDA Action
Executive Summary
Other proposals were broad in nature, and did not provide the agency with specific mechanisms to consider.
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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.
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.
FDA Looks Ahead To Complex Product-Specific Guidances
The agency offers a glimpse of its regulatory agenda, although several have been carried over through multiple list updates.