FORM FDA 2253 SUPPLEMENT (11/21) – INSTRUCTIONS
PSC Publishing Services (301) 443-6740 EF
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INSTRUCTIONS FOR COMPLETING FORM FDA 2253 – TRANSMITTAL OF ADVERTISEMENTS
AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
(The item numbers below correspond to the numbered boxes on Form FDA 2253)
1. Date Submitted – The date the 2253 Form and accompanying materials are sent to the FDA. Use drop-
down calendar or MM/DD/YYYY format.
2. Application Information – Provide the application type (New Drug Application (NDA), Abbreviated New
Drug Application (ANDA), Biologics License Application (BLA), Premarket Approval Application (PMA), or
CDER Investigational New Drug (CDER IND) from the drop-down followed by the application number.
For CBER BLAs enter the supplement number, if known.
Note: CDER Investigational New Drug (CDER IND) should only be used when submitting promotional
materials for an authorized CDER EUA. Provide the IND application number for the IND associated with
the authorized EUA.
Select either single product or multiple products:
• Single product – Each 2253 Form and accompanying submission should pertain to only one
application number. For paper submissions, the completed Form and the attached submission
materials should be prepared in duplicate, and should be separated for ease of handling.
• Multiple products – A multiple product submission is used for cases where promotional materials
mention multiple products such as price lists, formulary lists, multiple product reminder ads, and
corporate communications. A single application number should be listed on the 2253 Form and the
other application numbers should be included on an attached sheet(s) which identies the other
referenced products including: application type and number, trade name and established name.
Labeling for each referenced product should be included. For non-eCTD and paper submissions,
three specimens of the promotional piece should be led to a single application with three 2253
Forms and labeling, and three copies of the attached sheet(s) showing other referenced products as
described above.
3. Proprietary Name – Enter the proprietary name of the drug or biological product. The dosage form
should also be included if it is part of the proprietary name or if it distinguishes the product from other
dosage forms with the same trade name.
4. Established Name – The established (generic) name of the drug/biological product. For biological
product submissions, provide “Product Code No.”, if known or used.
5. Package Insert Date and ID Number – The date and identication number of the most current product
labeling (include two copies for paper submissions).
6. Manufacturer Name and License No. – Provide the manufacturer name. Also include the license
number for biological product submissions.
7. Advertising/Promotional Labeling Materials – A detailed listing of all promotional materials submitted
on the 2253 Form. Each material should be individually listed per line. Individual components of
Formulary Kits and Professional and/or Consumer Kits should be listed separately. Add a new row
for each advertisement/ promotional labeling material. Consumer and professional pieces should be
submitted separately.
7a. Professional or Consumer – Select only one. If the materials are for mixed audiences, select one
audience (professional or consumer) based on the intended primary audience. If the materials will be
viewed by both professionals and consumers, note this in the Comments section (8f).
7b. Material Type – List materials submitted using the FDA Codes listed below (please see next page).
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FDA CODE TRANSLATION
Audio . . . . . . . . . . . . . . . . . .Audio Media (e.g. audio formats other than Internet Audio)
Book . . . . . . . . . . . . . . . . . .Book
Carrier . . . . . . . . . . . . . . . . .Reprint Carrier (e.g. a folder or detail piece that houses a reprint)
Carton . . . . . . . . . . . . . . . . .Sample Carton (e.g. a box or container that houses a drug sample)
Catalog . . . . . . . . . . . . . . . .Catalog (e.g. a pamphlet or book containing a systematically arranged list or record
of items or products)
CD-ROM . . . . . . . . . . . . . . .CD ROMS/Programs/Discs (e.g. a CD ROM that is distributed to health care
professionals or consumers that does not fall into one of the other material types)
Corrective Internet . . . . . . . .Corrective Internet (e.g. corrective materials such as websites, Internet audio, or
Internet video related to a Warning letter)
Corrective Letter . . . . . . . . .Corrective Letter (e.g. corrective letter to health care professionals or consumers or
other printed correctives related to a Warning letter)
Corrective Print Ad. . . . . . . .Corrective print advertisement related to a Warning letter
Corrective TV. . . . . . . . . . . .Corrective TV (e.g. corrective television advertisement related to a Warning letter)
Direct Mail . . . . . . . . . . . . . .Direct Mail (e.g. printed non-electronic materials mailed directly to individuals)
Drug Sample . . . . . . . . . . . .Drug Sample (e.g. a small quantity of prescription drug not intended to be sold and
given to prescribers for dissemination to patients)
Electronic Detail Aid. . . . . . .Electronic Detail Aid (e.g. electronic detail aids, sales aids, or applications used by
sales representatives to detail the product)
Exhibit . . . . . . . . . . . . . . . . .Exhibit (e.g. electronic or non-electronic item(s) set out for public display such as
vertical panels)
File Card . . . . . . . . . . . . . . .File Card
Form . . . . . . . . . . . . . . . . . .Form (e.g. form for subsidy or patient support form)
Formulary Economic.. . . . . .Formulary Economic (e.g. material containing cost information about a product
provided to a formulary committee)
Formulary Kit. . . . . . . . . . . .Formulary Kit (e.g. packaged set of materials about a product provided to a
formulary committee)
Giveaway. . . . . . . . . . . . . . .Giveaway
House Organ. . . . . . . . . . . .House Organ (e.g. a periodical issued by a company dedicated to presenting news
about the rm, its products, or its personnel)
Kit . . . . . . . . . . . . . . . . . . . .Kit (e.g. a packaged set of related materials such as a sales kit)
Monograph . . . . . . . . . . . . .Product Monograph
PDURS . . . . . . . . . . . . . . . .Prescription Drug Use Related Software
Press Release. . . . . . . . . . .Press Release
Print Ad . . . . . . . . . . . . . . . .Print Advertisement
Promotional Labeling. . . . . .Promotional Labeling (e.g. generally any labeling other than FDA-required labeling
that is devised for promotion of the product such as brochures, booklets, or price lists.
Use this category when materials do not fall into one of the other material types.)
Radio. . . . . . . . . . . . . . . . . .Radio (e.g. audio broadcast over radio waves, can include the script)
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FDA CODE TRANSLATION
Reply Card. . . . . . . . . . . . . .Reply Card
Reprint. . . . . . . . . . . . . . . . .Reprint (e.g. a reproduction of printed material that has previously appeared in print)
Sales Aid . . . . . . . . . . . . . . .Sales Aid (e.g. print sales aid or detail aid)
Slides. . . . . . . . . . . . . . . . . .Slides (e.g. professional or consumer slide presentations including ofcial notes or
mandatory talking points)
Telephone . . . . . . . . . . . . . .Telephone (e.g. script for telephone calls)
Training Materials . . . . . . . .Training Materials (e.g. learning modules, training video/brochure/other piece(s)
provided to health care professionals or patients)
TV . . . . . . . . . . . . . . . . . . . .Television Advertisement
Video . . . . . . . . . . . . . . . . . .Video (e.g. video other than a Video News Release or Internet Video)
Video News Release . . . . . .Video News Release (e.g. video provided to television newsrooms)
www-audio. . . . . . . . . . . . . .Internet Audio (e.g. podcast or audio conference)
www-banner . . . . . . . . . . . .Internet Banner (e.g. a banner that is intended to be embedded into a web page.)
www-ecomm . . . . . . . . . . . .Internet Electronic Communication (e.g. email directed to health care professionals
or consumers)
www-links . . . . . . . . . . . . . .Internet Link (e.g. sponsored links)
www-mobile. . . . . . . . . . . . .Mobile Technology (e.g. smartphone or tablet app/widget, quick response (QR)codes,
mobile websites)
www-soc-med . . . . . . . . . . .Internet Social Media (e.g. social networking, microblog/blog, online community, wiki)
www-video. . . . . . . . . . . . . .Internet Video
www-website . . . . . . . . . . . .Internet Website
7c. Dissemination/Publication Date – The date of the initial dissemination/publication of the promotional
labeling piece or advertisement. Use drop-down calendar or MM/DD/YYYY format.
7d. Material ID Code – The applicant’s identication code or other designation of the specic
promotional material.
7e. Material Description – The applicant’s description of the specic promotional material.
7f. Comments – Include any information that is pertinent to the dissemination method of the materials. Also
include a comment if a piece is meant to be disseminated exclusively with other pieces and indicate the
accompanying pieces.
8. Applicant (or Agent’s) Return Address, including the country.
9. a, b, & c. Telephone Number, FAX Number, and Email Address – The telephone and facsimile
numbers and email address of the responsible ofcial or agent.
10. Typed Name and Title of Responsible Ofcial or Agent – The individual responsible for responding to
any inquires regarding the 2253 submission.
11. Signature of Responsible Ofcial or Agent
12. Date – Date of signature. Use drop-down calendar or MM/DD/YYYY format.
13. Biological products – For CBER products only, draft or nal.
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NOTE:
Forward Form and attachments for drugs and therapeutic biologic products to: Food and Drug
Administration, Center for Drug Evaluation and Research, Ofce of Prescription Drug Promotion, 5901-B
Ammendale Road, Beltsville, MD 20705
Forward Form and attachments for biologics to: Food and Drug Administration, Center for Biologics
Evaluation and Research, Document Control Center, 10903 New Hampshire Avenue, Building 71, Room
G112, Silver Spring, MD 20993-0002
