OPDP Form FDA-2253 submissions

According to 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.  Please submit professional and consumer materials separately.  Please do NOT include a cover letter.  All materials, both paper and electronic format, must be submitted in duplicate.  Please be sure to use the most current version of Form FDA-2253, available below on this website.  

Please include in the submission:

• Form FDA-2253 - Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use [PDF]
• For CDER Biologic Drug Products:  On Form FDA-2253, Box 13 titled "Biological Products," please do NOT check the "Part I/Draft" or "Part II/Final" boxes.  This form should be submitted with FINAL promotional materials only.
• Promotional materials - Materials can be submitted in paper or electronic format.  Please consult the following draft guidance for information on submitting materials in electronic format:
  • Draft Guidance -  "Guidance for Industry Providing Regulatory submissions in Electronic Format -- Prescription Drug Advertising and Promotional Labeling" (1/31/01)  [PDF]
• Current approved Package insert and, if applicable, Medication Guide/Patient Package Insert