Jul. 3 at 11:20 PM
$UNCY • No formal mechanism to unilaterally extend: Under PDUFA, FDA commits to review-cycle deadlines in exchange for user fees. There’s no provision letting FDA just push the date on its own — the clock is contractual/statutory, not discretionary. FDA can only “restart” the clock via a Class 1 or Class 2 resubmission (2-month or 6-month re-review), which is exactly what’s happening here.
• CRL is the formal off-ramp: If FDA can’t complete all required elements (including facility inspection) by the goal date, its only compliant path is to issue a CRL. It legally can’t approve without inspecting a manufacturing site tied to the application, and it can’t just sit on the application past the deadline without action — that would create its own compliance problem for FDA under PDUFA performance metrics that Congress and industry track closely.
