ODINSIGNAL JOURNAL · NEWS & EVENTS
FDA Decision on D‑PLEX100 Scheduled for 28 Nov 2026
The FDA’s PDUFA deadline for D‑PLEX100, a surgical‑site infection preventive, is set for 28 Nov 2026. Follow updates on OdinSignal.
At a glance
- Event
- D-PLEX100 - prevention of surgical site infections
- Date
- 2026-11-28
- Participants
- FDA
The FDA’s PDUFA calendar lists a decision deadline for the antimicrobial polymer D‑PLEX100 on 28 Nov 2026. The entry appears under the PYPD ticker as “PYPD Micro D‑PLEX100 – prevention of surgical site infections · PDUFA 2026‑11‑28” on the independent PDUFA calendar. This date marks the agency’s deadline to either approve the product or issue a complete response letter. As of today the outcome remains pending, and the decision will determine whether D‑PLEX100 gains market authorization for preventing surgical‑site infections. Stakeholders will be watching the FDA’s assessment closely, given the potential impact on infection control in operative settings. No time, venue, or additional details have been disclosed.
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