The promotional labeling and advertising materials, together known as promotional materials for human prescription drug products, are to be submitted to the FDA (Food and Drug Administration) once the drug product has been approved by the FDA. These submissions are processed on a 2253 form, which is the Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use. Form 2253 is required for approved new drug applications (NDAs), Abbreviated New Drug Application (ANDAs), Biologic Licensing Applications (BLAs), and the submissions are made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER). These submissions are essential for every pharmaceutical company as it aids in marketing their pharmaceutical drug products approved by the FDA.
Promotional labeling is different than the FDA regulatory labeling requirements and focuses on promoting drug products. There are various types of promotional materials that include videos, websites, telephone communications, print ads, television ads, social media ads, and much more.
The FDA currently receives various types of advertising and promotional submissions either in eCTD format, or in a non-eCTD format that includes Form FDA 2253 submissions, Pre-submission of promotional materials for Accelerated Approval Products (Subpart H and E), promotional materials for Advisory comments, Resubmissions, General correspondence, Amendments, Withdrawal requests, Response to warning letters, Response to Information requests, Reference documents, and Complaints.