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FDA Guidance:Providing Submissions in Electronic & Non-Elec Format—Promotional Labeling &Advertising

FD&C Act defines labeling as “all labels and other written, printed, or graphic matter

(1) upon any article or any of its containers or wrappers, or

(2) accompanying 110 such articles” (21 U.S.C. 321(m))

Promotional labeling is generally any labeling, other than the FDA-required labeling, that is devised for the promotion of the product. Promotional materials may include, but are not limited to, television, advertisements (ads), brochures, booklets, detailing pieces, internet websites, print ads, exhibits, sound recordings, and radio ads. Examples of materials that may be considered promotional labeling pieces for prescription drugs are described in 21 CFR 202.1(l)(2).

The guidance refers to submissions of promotional materials for human prescription drugs (drugs) to the Food and Drug Administration (FDA or Agency) by manufacturers, packers, and distributors (firms), whether the applicant or an entity acting on its behalf.

This guidance explains certain aspects of electronic submission of promotional materials in module 1 of the electronic common technical document (eCTD), using version 3.3 or higher of the us-regional-backbone file.

This guidance pertains to submissions made to the Office of Prescription 20 Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER).

This document also discusses types of promotional materials that are not subject to the 101 mandatory electronic submission requirements in section 745A.

Post 24 months after the issuance of this guidance, firms will be required to submit electronically all promotional submissions that fall within the scope of section 745A(a) as specified in this guidance.

To know more about the Content & Format and full details of this guidance click this LINK.


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