Rule CG-RES-002
Research recruitment: what rule CG-RES-002 checks
Rule CG-RES-002 is one of the checker's research recruitment rules. It cites 21 CFR 56.111(a)(3), 21 CFR 50.20. The reason, source and safer wording are below.
CG-RES-002 · Blocks approval · Citation checked against stored text
FDA says recruitment ads should not use "new treatment", "new medication" or "new drug" without explaining that the product is investigational, because it leads people to expect an improved product of proven worth.
Source: FDA information sheet "Recruiting Study Subjects"; 21 CFR 56.111(a)(3); 21 CFR 50.20
Safer wording: Say the product is investigational ("a study of an investigational drug that is not yet approved by the FDA").
21 CFR 56.111(a)(3), 21 CFR 50.20 · Needs counsel review
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