12/26/25 - SP 103 Fast Track Lidocaine Patch Development, Abbott TriValve Percutaneous Repair Clearance, FDA Food Traceability R

12/26/25 - SP 103 Fast Track Lidocaine Patch Development, Abbott TriValve Percutaneous Repair Clearance, FDA Food Traceability R

Episode description

This episode examines Scilex’s Fast Track designated SP 103 lidocaine patch targeting the ten billion dollar acute low back pain market, Abbott’s TriValve catheter based system cleared for dual valve regurgitation repair without open heart surgery, and FDA’s thirty month delay of Food Traceability Final Rule compliance from January 2026 to July 2028. The briefing covers rolling submission requirements for expedited drug development timelines, minimally invasive valve repair platform expansion, and traceability infrastructure readiness across higher risk food supply chains under Food Safety Modernization Act mandates.