Instructions For Submitting Form Fda-2253

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I NSTRUCTIONS 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. Label Review Number – If applicable, provide the previously assigned label review number from Form FDA
2567 “Transmittal of Labels and Circulars Form.”
3. NDA/ANDA/AADA or BLA/PMA – Provide the application type (New Drug Application (NDA), Abbreviated
New Drug Application (ANDA), Abbreviated Antibiotic Drug Application (AADA) or Biologics License Application
(BLA), Premarket Approval Application (PMA)) from the drop-down followed by the application number.
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 identifies 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 filed 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.
4. 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.
5. Established Name – The established (generic) name of the drug/biological product. For biological product
submissions, provide “Product Code No.”, if known or used.
6. Package Insert Date and ID Number – The date and identification number of the most current product
labeling (include two copies for paper submissions).
7. Manufacturer Name and License No. – Provide the manufacturer name. Also include the license number
for biological product submissions.
8. 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.
8a. 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).
8b. Material Type – List materials submitted using the FDA Codes listed below (please see next page).
FORM FDA 2253 SUPPLEMENT (4/14) – FORM INSTRUCTIONS
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EF
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