Rule CG-RFA-010

Outcome statistics: what rule CG-RFA-010 checks

Rule CG-RFA-010 is one of the checker's outcome statistics rules. It cites 21 CFR 202.1. The reason, source and safer wording are below.

CG-RFA-010 · Blocks approval · Citation checked against stored text
Promoting efficacy numbers for a drug, such as survival months versus a comparator, lab targets or a one-pill claim, without risk information and context misleads about benefit and is cited in FDA untitled letters.
Source: FDCA 502(n); 21 CFR 202.1; FDA OPDP untitled letters
Safer wording: Present efficacy data with fair balance, the study population, and the major risks in the same communication.
21 CFR 202.1 · Needs counsel review

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