Julie Chelius | Montgomery McCracken Walker & Rhoads LLP
There are certain key questions to keep in mind when creating promotional materials for prescription drugs and reviewing these materials for regulatory compliance:
• Is the content truthful and not misleading?
• Does the content present a full and balanced disclosure of risks and material facts?
• Are the product claims being made in the promotional material explicitly included within the indication approved by the FDA?
• Are the product claims supported by substantial evidence?