Advertising & Promotional Review (OPDP)

Advertising and promotional review ensures that product communications comply with U.S. FDA requirements and accurately reflect approved labeling. OPDP oversight focuses on protecting against misleading claims, imbalance of risk and benefit information, and unsupported promotional statements.

Promotional review activities typically involve evaluating promotional materials prior to dissemination to ensure alignment with FDA regulations, guidance, and enforcement precedent. This includes review of claims, visual elements, context, and supporting data.

Effective promotional review processes help organizations reduce regulatory risk while supporting compliant commercial communication throughout the product lifecycle.

Advertising and promotional review commonly addresses:

• Promotional claims and substantiation

• Risk–benefit presentation and balance

• Consistency with approved labeling

• Internal promotional review committee processes

• OPDP enforcement trends and expectations