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 and carefully read the submission instructions:
When submitting Form FDA-2253, please note the following:
Promotional materials can be submitted in paper or electronic format. Please consult the following draft guidance for information on submitting materials in electronic format:
Be sure to include the current approved Package Insert and, if applicable, Medication Guide/Patient Package Insert.