Updated: May 19
On June 21, 2019, FDA released the Finalized Guidance for Promotional Labeling and Advertising Materials for Human Prescription Drugs. The Original draft guidance was published in April of 2015. Below are a few key takeaways on the immediate transition activities:
With the finalization of this guidance, after 24 months, Ad Promo submissions that fall under Section 745A(a) of the FD&C Act are required, by law, to be submitted in eCTD format. These include:
Post-marketing submissions of promotional materials using Form FDA 2253
Submissions of promotional materials for accelerated approval products that fall under CFR 314.550 (subpart H) or 21 CFR 601.45 (subpart E), and require agency approval before distribution
Other product types that fall under section 505(b), (i), or (j) of the FD&C Act and also require approval similar to accelerated pathways
While other non-mandatory ad promo submissions (Correspondence, voluntary submissions of draft materials, etc.) can continue to be submitted in paper, it is highly recommended to harmonize all ad promo submissions into eCTD format.
In the transition period, both mandatory and non-mandatory submission types can still be submitted in paper. New activities are strongly suggested to be submitted in eCTD, but any amendments to submissions originally submitted in paper should continue to be submitted in paper.
If an amendment to a mandatory submission that was originally submitted in paper is needed after the 24-month probation period has passed, sponsors should contact the FDA to determine the best course of action.
In order to submit Ad Promo submissions in eCTD format, sponsors MUST use Module 1 version 3.3 (CDER submissions to OPDP must use v3.3 currently. CBER submissions to APLB may utilize older versions of the M1 spec, but after the transition period, v3.3 must be utilized).
Are you ready to be compliant? WAYS Pharmaceutical Services is monitoring regulatory submission guidances and we are constantly interacting with health authorities. Follow the WAYS page on LinkedIn so you can see the insights we share on a regular basis, and feel free to reach out directly to us with any questions.