Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Industry Engagement topic
No spam. Unsubscribe anytime.
FDA details how industry can engage on PSGs via controlled correspondences, comments and TCONs
Summary
The presenter explained routes for industry engagement: controlled correspondences can be triaged as public requests via the CDER Direct Next Gen portal; docket comments are accepted under a Federal Register notice; PSG TCONs and meetings can be requested with eligibility criteria and in 2025 there were two PSG TCONs requested and granted.
The presenter walked through how applicants and stakeholders can interact with the PSG process. Controlled correspondences (CCs) submitted through the CDER Direct Next Gen collaboration portal may be triaged as public requests when seeking general BE recommendations for an RLD lacking a PSG. For complex products, submitters may instead request a pre‑ANDA meeting. The presenter said ORS triages such requests and prioritizes them alongside GDUFA goal dates.
The presenter also described the PSG teleconference (TCON) and meeting processes: a PSG TCON may be requested when the BE recommendation is for an in‑vivo study and an ANDA applicant has already commenced an in‑vivo BE study; PSG meetings provide a forum to discuss scientific rationale after a PSG TCON. The presenter reported that in calendar year 2025 there were "2 PSG TCONs requested, 2 PSG TCONs granted" and that no PSG meetings were requested in 2025.
