US FDA Overview & Product Jurisdiction Compliance

Under FD&C Act, the manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, are required to disclose in advertisements certain information about the advertised product's uses and risks.

A US manufacturer is applying this compliance for their recently approved drug product with black box warning. This product is suitable for broad range of adult population as a prescription (Rx) therapy. They do not have any clinical data evaluated for the pediatric population, though they are planning to do additional clinical studies in the future.

The manufacturer is intending to present in their broadcasted advertisements both populations groups information. Assess this scenario and review the reference guidance provided (attached). Write your viewpoint regarding what are the consideration which should apply to this manufacturer to ensure that their broadcasted advertising remains complaint from regulatory perspective?

chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/files/about%20fda/published/Consumer-Directed-Broadcast-Advertisements-%28PDF-version%29.pdf

Use the above link for this assignment and provide the 2 to 3 pages brief answer on it with references.