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