Each reviewer checks the content from a different angle. Medical checks scientific accuracy and that claims are supported by evidence. Legal checks for legal risk, such as misleading or unsupported claims. Regulatory checks compliance with advertising rules and consistency with the approved product labeling.
Why it matters for labeling
Promotional content has to stay consistent with the approved labeling. In the US, that means the FDA-approved prescribing information; in the EU, the summary of product characteristics (SmPC). Most promotional materials for US prescription drugs and biologics are also submitted to FDA on Form FDA 2253 at the time of first use, and the version submitted must match the version used.
Common mistakes
- Reviewers commenting on, or approving, different versions of the same piece
- Claims that can't be traced back to the approved source or a supporting reference
- Derivative formats, such as banners or social posts, drifting from the approved master
- Changes made after approval without going back through review