FDA Ad Promo Submissions - OPDP 2253

Regulatory compliance is non-negotiable in the drug approval process for the pharmaceutical and biotech sectors. Under 21 CFR 314.81(b)(3)(i) for drugs and 21 CFR 601.12(f)(4)) for biologics, once a product has been approved, any materials intended for promotional use must be submitted to the FDA at the time they are first distributed. These submissions must include FDA Form 2253, titled "Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use," and are commonly known as "2253 submissions.”

For seamless execution of 2253 Ad Promo Submissions to the FDA, the pharma industry turns to Freyr for its expertise. With years of experience and a proven track record, we are your trusted partner in navigating the complex landscape of ad-promo submissions.

Expertise You Can Trust

At Freyr, our team is highly skilled in handling 2253 Ad Promo Submissions for the USFDA. We have developed expertise in this area through extensive work with clients of all sizes, from large corporations to small businesses. Whether you need help with the submission process or strategic advice on 2253 Ad Promo requirements, Freyr is ready to streamline your workflows, provide cost-effective solutions, and ensure quick turnaround times with our dedicated team.

List of activities Freyr can support with ad promo submissions:

• Collection of promotional materials such as advertisements, labeling, brochures, websites, social media content, and any other materials intended for public consumption
• Creation of binders
• Creation of 2253 Forms
• Creation of storyboard for Spanish materials
• Create eCTD submission output
• Final validation, QC, and delivery

Types of 2253 Submissions

Office of Prescription Drug Promotion (OPDP)- 2253 submissions include promotional materials aimed at both:

• Healthcare Professionals (HCPs)
• Consumers (patients)

These submissions cover a range of materials, from educational content for physicians to direct-to-consumer advertisements. They are essential for ensuring that accurate and compliant information about drug products is disseminated effectively.

Meticulous Documentation

To ensure thorough submissions, adherence to metadata requirements is essential. From applicant information to additional metadata elements, our team meticulously compiles all necessary documentation, including the 2253 Form (Module 1.1), Current Product Labeling (Module 1.14.6), and Promotional Material Clean Version (Module 1.15.2.1.1), facilitating the review process.

Efficient Dispatch to FDA

Upon compilation and verification of required documentation, submissions are dispatched to the appropriate FDA centers—CDER (Center for Drug Evaluation and Research) or CBER (Center for Biologics Evaluation and Research)—ensuring efficient processing and review.

Archival Process

In addition, the Freyr team is competent in processing the archival of the submission, receipts & acknowledgments for internal tracking.