GDF2026 - Product-Specific Guidances (PSGs) in Action – Key Lessons and Common Questions
FDA workshop on product-specific guidances (PSGs) · July 30, 2026
An FDA agency official presented updates to product-specific guidances (PSGs) at an agency workshop, describing changes from the M13a guidance that reduced recommended BE studies for many immediate-release oral products, explaining BCS-based waiver approaches and suitability petitions, and urging applicants to submit supporting data. The presenter emphasized transparency and that PSGs are guidance (not requirements).
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