Advertising & Promotional Review (OPDP)

Advertising and promotional review under FDA OPDP (and APLB for biologics as applicable) protects against misleading claims, unfair risk-benefit balance, and materials that stray from approved labeling. Review covers branded ads, digital campaigns, sales aids, congress materials, websites, and speaker content. Enforcement history shows that speed without discipline creates untitled or Warning Letters and costly remakes after assets are already in market or with sales forces.

Viltis supports promotional review processes that commercial teams can live with. We help stand up or strengthen MLR/PRC committees, claim matrices tied to labeling, and review workflows with clear owners and turnaround expectations. Reviewers look at claims, context, visuals, footnotes, and substantiation so materials remain fair and accurate before dissemination, including digital placements and paid search that change faster than traditional print kits.

We also coach teams on how OPDP thinks about comparative claims, superiority language, and social or interactive media. The work is not about saying no to every creative idea; it is about catching problems while there is still time to fix them, and documenting decisions for inspection. When findings arrive, we help remediate process gaps, not only the single piece that triggered FDA attention.

A claim matrix that maps each promotional statement to labeled language and supporting studies shortens debate in committee and gives new brand managers a shared reference instead of tribal knowledge. That same matrix becomes useful evidence when investigators ask how a claim was approved for use. Launch waves and congress seasons create volume spikes; we help you staff review capacity and triage rules so high-risk claims get deeper review while lower-risk updates move without becoming a bottleneck for the brand calendar.

OPDP-related support commonly includes

• MLR/PRC process design, charters, and RACI models
• Pre-dissemination review of promotional and medical education pieces
• Claim substantiation packages linked to labeling and studies
• Training for brand, agency, and medical review participants
• Monitoring of OPDP enforcement letters and guidance updates
• Remediation after FDA untitled or warning letter findings
• Digital and social content controls for regulated product promotion

Promotional compliance is a daily operating discipline. Viltis helps you keep marketing ambitious and still defensible when FDA asks how a claim was approved and who signed off.