Policy· May 22, 2026 · 11 min readLabeling supplement timing after a new indication approval and why launch teams miss itWhen FDA approves a supplemental NDA or BLA for a new indication, the new labeling must be in effect before the sponsor can promote...By Ran Chen#FDA Approval#Regulatory#Post-Approval Changes
Policy· May 22, 2026 · 10 min readPostmarketing requirement tracker for accelerated-approval products after launchAccelerated-approval products carry open PMRs that can trigger withdrawal if milestones slip. This article maps the FDA tracking...By Ran Chen#FDA Approval#Regulatory#Postmarketing Requirements