Submitting Biologics Advertising & Promotional Labeling
The Center for Biologics Evaluation and Research (CBER) reviews final and draft professional and direct-to-consumer (DTC) advertising and promotional labeling materials submitted for licensed biological products, including vaccines, allergenic extracts, blood products, gene therapy products, and certain medical devices and test kits regulated by CBER. CBER also reviews promotional materials to ensure that information about the product’s risks and benefits are communicated in a truthful, non-misleading, and balanced manner, and are in compliance with pertinent federal laws and regulations.
The following instructions are to be used for submitting Final Materials, Draft Materials, and Materials for Products Approved Under Accelerated Approval.
Links to the required Form FDA-2253 "Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use," and information about Electronic Submissions are at the end of this page.
Final advertising and promotional labeling materials may be submitted in paper or electronic format by sponsors/applicants. Submissions must contain the following items:
- Form FDA-2253 - Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (check box #13 “Part II/Final)
- 2 copies of final advertisements and promotional labeling materials
- 2 copies of the product’s current professional labeling (for example, Approved Package Labeling (PI), Patient Package Insert (PPI), medication guide, and instructions for use)
Note: Advisory comments can be requested on draft promotional pieces that have not been published or disseminated and are not currently in use and they may be submitted in paper or electronic format. Sponsors/applicants may submit the same items that are noted above for final materials, but box #13 “PartI/Draft” should be checked on the Form-2253.
Draft "Direct to Consumer (DTC)" TV advertising and promotional labeling materials also may be submitted in paper or electronic format. In addition to the above items, these submissions should contain the following items:
- Two copies of:
- Annotated Storyboard, with sequentially numbered frames
- Video or animatic of the proposed advertisement, in one of the following media formats:
- MPEG-2-HD (High Definition Video)
- WMV-HD (High Definition Video)
- CD-R and CD-RW
- .iso files
- Audio_ts/video_ts folders that include the following formats:
Unless otherwise informed by the agency, all advertising and promotional materials that are intended for dissemination or publication within 120 days following marketing approval must be submitted to the agency for review during the pre-approval review period with Form FDA 2253 Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use (check box #13 “Part I/Draft”) . Furthermore, after 120 days following marketing approval, all advertising and promotional materials must be submitted at least 30 days prior to the intended time of initial dissemination or publication with Form FDA 2253 Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use. [21 CFR 314.550 and 21 CFR 601.45]
Information about Form FDA-2253 "Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use"
Under 21 CFR 314.81(b)(3)(i):
- All advertisements and promotional labeling for a particular drug product must be submitted at the time of initial publication or dissemination.
- Each submission is required to be accompanied by a completed transmittal Form FDA-2253.
- Form FDA 2567 is equivalent to Form FDA 2253.
For information on electronic submissions (eSubmissions), refer to:
- FDA Electronic Submissions Gateway (ESG) for submitting electronic copies of promotional materials.
- Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format -- Prescription Drug Advertising and Promotional Labeling
- Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
- Electronic Submissions Gateway
Information on how to submit documents to FDA electronically
- 21 CFR (Code of Federal Regulations)
- Regulatory Submissions in Electronic Format for Biologic Products