Regulatory Open Forum

Hi everyone, 

Could you share how your team or company addresses situations where sale/marketing teams proposes terms for publication that don't align with regulatory requirements, therefore not approved by the regulatory team?

Thank you!

All publications and marketing materials should be reviewed by a Promotional Review or Medical Review Committee that is authorized by the organization to review and approve the materials from a medical, legal and regulatory point of view. Scientific communications that are not promotional do not require regulatory approval, but any use by sales and marketing as part of their promotional activities does require regulatory approval to assure that the company is compliant with the labeling regulations. Failure to do so could have serious repercussions.

Hi everyone, 

Could you share how your team or company addresses situations where sale/marketing teams proposes terms for publication that don't align with regulatory requirements, therefore not approved by the regulatory team?

Thank you!