APPENDIX 3 - 21 CFR Regulation

APPENDIX 3

Regulations Cited in ICR

21 CFR 202.1(e)(6)(i)

(6) Advertisements that are false, lacking in fair balance, or

otherwise misleading. An advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n) of the act, among other reasons, if it:

(i) Contains a representation or suggestion, not approved or

permitted for use in the labeling, that a drug is better, more

effective, useful in a broader range of conditions or patients (as used

in this section patients means humans and in the case of veterinary

drugs, other animals), safer, has fewer, or less incidence of, or less

serious side effects or contraindications than has been demonstrated by

substantial evidence or substantial clinical experience (as described in paragraphs (e)(4)(ii) (b) and (c) of this section) whether or not such representations are made by comparison with other drugs or treatments, and whether or not such a representation or suggestion is made directly or through use of published or unpublished literature, quotations, or other references.