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Promotional Material Document Type
Definition 1
The type of document used as promotional material. (NCI Thesaurus)
Definition 2
A description of the regulatory purpose of the promotional labeling or advertising material. (Food and Drug Administration)
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A description of the audience of promotional labeling or advertising material. FDA Form 2253.
Promotional labeling and advertising pieces including, but not limited to, the items listed in 21 CFR 202.1(l)(1) and (2).
Promotional labeling is generally any labeling other than the FDA-required labeling that is devised for promotion of the product. Promotional labeling may…
Television advertisements submitted to FDA for pre-dissemination review in compliance with section 503B of the Federal Food, Drug, and Cosmetic Act. …
Form and materials required from a submitter at first publication of marketing and advertising materials. 21 CFR 314.81(b)(3)(i) and 601.12(f)(4)
