promo-materials-review-policylisted

# Promotional Materials Review Policy Drafts a formal internal policy ensuring all promotional materials comply with the FD&C Act and FDA promotional regulations (21 CFR Parts 201, 202). ## Prerequisites 1. **Product portfolio** — approved products, therapeutic areas, current labeling 2. **Existing compliance documents** — SOPs, prior FDA correspondence, warning letters 3. **Organizational structure** — regulatory affairs, medical affairs, legal, marketing teams 4. **Distribution channels** — print, digital, social media, sales force, CME involvement ## Quick Start Gather prerequisites, then draft a numbered policy document with table of contents, definitions, and appendices covering: (1) Purpose & Scope, (2) Promotional Review Committee, (3) Submission & Review Procedures, (4) Fair Balance, (5) Substantiation Standards, (6) Off-Label Prohibitions, (7) Recordkeeping, (8) Training, (9) Monitoring & Auditing. Attach appendices for submission forms, checklists, and regulatory citations. ## Output Structure ### 1. Purpose & Scope | Element | Requirement | |---|---| | Objective | All promotional materials truthful, balanced, non-misleading, FDA-compliant | | Covered materials | Ads, sales aids, digital/social media, websites, email, trade shows, product-specific patient education, CME with promotional elements, mobile apps | | Covered personnel | Employees, contractors, agencies, medical education companies, all third parties acting on company's behalf | | Enforcement | Vi