As of June 24th, 2021, the FDA will no longer accept paper submissions for Promotional Labeling and Advertising Materials (Form 2253 Submissions). Aquila Solutions recommends changing to eCTD format submissions as soon as possible to best prepare for the mandate.
If you currently submit paper 2253 Submissions, the move to eCTD will also necessitate your application’s future sequences be submitted in DTD 3.3 (the latest version of eCTD). Aquila Solutions is equipped to help you seamlessly transition to this version of eCTD, while promptly publishing and meeting the highest quality standards. We also offer 2253 submissions consulting support alongside your current publishing system.
Aquila Solutions can be your publisher of any future 2253 Submissions with 24 hour turnarounds and attention to detail.
Contact us today for additional information on getting your promotional material submission completed. Our experienced and knowledgeable team is ready to work on your submission.
Marketing Requirements from OPDP:
When do promotional materials need to be submitted to OPDP?
Pursuant to 314.81(b)(3)(i), submissions must be made ” . . . at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product.”
Do all promotional materials for prescription drugs have to be submitted to OPDP?
The regulations for submitting materials apply to holders of NDAs, ANDAs, and antibiotic applications. Manufacturers of pre-1938 products and products that have been declared “not new drugs” are not required to submit specimens. All products have labels and prescribing information, however, and products without approved labeling have permitted labeling. Permitted labeling indicates FDA agrees with the label or labeling and permits its use. A manufacturer of a product with “permitted” labeling is responsible for assuring that advertisements and promotional labeling pieces are consistent with the product labeling.
To whom should I send the materials?
Please see draft guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs for information on how to submit. FDA began accepting eCTD submissions using the new M1 specifications June of 2015. [FDA will require electronic submission on June 24th, 2021]
Does FDA "approve" advertisements and promotional labeling before use by the company?
No, pre-approval of promotional materials is not required except in rare instances. For example, FDA may require pre-approval of promotional materials as part of a compliance action. However, OPDP provides opinions on proposed advertisements and labeling pieces before use upon request by an applicant. Note that accelerated approval products are under a “presubmission” requirement. The accelerated approval regulations require that applicants submit to FDA copies of all promotional materials prior to the intended date of dissemination or publication.