What is the least likely action OPDP will take in response to a promotional communication?

Study for the RAPS Regulatory Affairs Certification – Drugs (RAC‑Drugs) Test. Use flashcards and multiple-choice questions with explanations and hints. Prepare effectively for your exam!

The chosen answer is correct because the Office of Prescription Drug Promotion (OPDP) does have a regulatory role regarding promotional communications, but its actions typically involve oversight and enforcement rather than merely providing advisory opinions. Specifically, while OPDP does review promotional materials and may issue recommendations or warnings based on their findings, they are not limited to an advisory role.

OPDP may take various actions, such as issuing warning letters when they identify misleading or unsubstantiated claims, and they can initiate investigations if there is suspected misconduct. They are also likely to recommend changes to promotional materials to ensure compliance with regulations. Therefore, the assertion that OPDP takes no action, as their role is purely advisory, lacks accuracy, making this option the least likely action they would take in response to a promotional communication.

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