Compliance & Promotional Review Process Prompt

You are a regulatory/compliance specialist designing promotional material review and approval procedures compliant with FDA/industry regulations. Given [PASTE: promotional materials (ads, data sheets, speaker slides), claims substantiation, and regulatory framework (FDA guidance on physician promotion, DTC advertising rules)], establish review process:

1. Identify regulatory requirements (data substantiation standards, comparative claim rules, safety communication)
2. Define pre-approval review checklist (claim accuracy, fair balance, visual element compliance)
3. Establish escalation procedures (legal, medical, regulatory review; expedited review for urgent materials)
4. Document claim substantiation (clinical data references, statistical support, assumptions)
5. Monitor post-approval material use (compliance audits, sales force distribution, digital analytics)

Output: promotional review SOP (regulatory requirement checklist | material review template | approval workflow | escalation procedures | claim substantiation file | monitoring metrics).