Where do the regulations state the requirement for submitting prescription drug advertisements and labeling?
Under 21 C.F.R. 314.81(b)(3)(i): Section 314.81 Postmarketing reports. ***** (b) Reporting requirements. The applicant shall submit to the Food and Drug Administration at the specified times two copies of the following reports: ***** (3) Other reporting–(i) Advertisements and promotional labeling. The applicant shall submit specimens of mailing pieces and any other labeling or advertising devised for promotion of the drug product . . . .
