Updates to the FDA’s Ad Promo Guidance

The FDA ad promo guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs was updated earlier this month. Minor changes are described below:



  • The guidance includes updated links for the Center for Drug Evaluation (CDER) and Center for Biologics Evaluation Research (CBER) guidance repositories:

  • CDER: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs

  • CBER: https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances

  • Footnote 1 - This footnote has an added statement: You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2015-D-1163 (available at https://www.regulations.gov/docket/FDA-2015-D-1163).

  • Section 1 Introduction, now clarifies “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way unless specifically incorporated into a contract.” Note: Remember this is a unique guidance that has both binding and non-binding elements. The overall specifications are just guidelines, but the submission types that are required to be in electronic common technical document (eCTD) format are mandatory. Footnote 12 – This footnote includes updated links to the FDA Form 2253 form/instructions.

  • Footnote 14 – now provides an email address to inquire about the Office of Prescription Drug Promotion OPDP reviewer assignments - CDER-OPDP-RPM@fda.hhs.gov.

  • Section IV.B – This section further clarifies that Box 14 on the FDA Form 2253 is “For CBER Products only."

To learn more about Ad Promo submissions, check out our webinar titled, Ad Promo Submissions: Preparing for the eCTD Mandate. If you have additonal questions about your submissions, contact the WAYS team today.


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