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FDA describes SME triage teams to speed complex product PSGs

U.S. Food and Drug Administration (FDA) · July 30, 2026
AI-Generated Content: All content on this page was generated by AI to highlight key points from the meeting. For complete details and context, we recommend watching the full video. so we can fix them.

Summary

The presenter said the SME Triage Team (STT) program, a cross‑office effort started in 2021, connects research, review and policy SMEs to identify knowledge gaps and accelerate PSG development for complex products under GDUFA‑3.

The presenter described the SME Triage Team (STT) program as a cross‑office initiative launched initially as a 2021 pilot and made fully operational under GDUFA‑3. The presenter said the STT "successfully connects research and review assessment with PSG development, achieving early and proactive identification of knowledge gaps and timely addressing technical needs."

According to the presenter, STT teams are organized by product complexity areas (for example, topical products, inhalations, peptides) and include experts from research, review and policy to help plan PSG development timelines and meet GDUFA‑3 goal dates for complex products.

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