Rule CG-TRA-011
Regulatory status: what rule CG-TRA-011 checks
Rule CG-TRA-011 is one of the checker's regulatory status rules. It cites 21 CFR 202.1. The reason, source and safer wording are below.
CG-TRA-011 · Blocks approval · Citation checked against stored text
Branded prescription drug ads that name the drug and a benefit without the required risk information and fair balance, or that say side effects are rare, are misbranding.
Source: FDCA 502(n); 21 CFR 202.1 (prescription drug advertising, fair balance); FTC Act section 5
Safer wording: Include the major risks and indications as required for prescription drug advertising, and do not downplay side effects.
21 CFR 202.1 · Needs counsel review
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