Under FDA regulations, most promotional labeling and advertising for prescription drugs and biologics must be submitted to FDA's Office of Prescription Drug Promotion (OPDP) at the time of initial dissemination or publication, with the form as the transmittal. The submission identifies the material and the version being used.

Why it matters for labeling

The version submitted has to be the version in use. If a piece is changed after approval and the submission was made on an earlier version, the record doesn't match what the public sees. Recent FDA untitled letters have also cited companies for failing to submit materials, such as webpages, before they were published.

Common mistakes

  • Submitting an earlier draft instead of the final file
  • Changes after MLR approval without a new submission where one is required
  • Missing channels such as webpages or social content
  • Not keeping a record of which version was submitted

Sources