New FDA bonus pilot to address 'workforce challenges'
Max Bayer / endpoints - A new bonus pilot program meant to reward fast-working FDA reviewers will be funded in part by money from industry user fees, the first details on how Commissioner Marty Makary plans to finance the incentive ...
AI Summary: The FDA has introduced a pilot program offering performance bonuses to expedite regulatory reviews, aiming to tackle reviewer workload and improve timeliness. Funded partly by industry user fees, the initiative seeks to reward faster, high‑quality reviews while balancing independence and efficiency—proof that carrots sometimes replace the endless stick of overtime.
FDA lifts hold on Intellia trial
Ella Jeffries / beckershospitalreview - The FDA has lifted a clinical hold on Intellia Therapeutics’ phase 3 Magnitude trial of nexiguran ziclumeran, or nex-z. The trial was paused Oct. 29 after a patient developed grade 4 liver transaminase elevations and elevated bilirubin following a Sept. 3…
AI Summary: The FDA has lifted clinical holds on Intellia Therapeutics’ Phase 3 gene‑editing trials, allowing the company to resume patient enrollment and advance its nexiguran (nex‑z) development program. Regulators appear satisfied with submitted safety updates, clearing a major regulatory hurdle and moving the gene-editing program back toward its clinical milestones.