Final Guidance and Implementation Date
The U.S. Food and Drug Administration (FDA) has released long-anticipated final guidance with the implementation date for all promotional materials submissions via electronic common technical document (eCTD) format. The guidance titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” defines ‘FDA-required labeling’ as any labeling reviewed and approved by FDA as part of the marketing application review process. This guidance requires post-marketing submissions of promotional materials and submissions of promotional materials for accelerated approval products be submitted via eCTD format starting June, 2021. Now is the time to start preparing to adopt and implement this process.
A copy of the final guidance can be found here. In summary, the guidance states that the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling branch (APLB) in the Center for Biologics Evaluation and Research (CBER) will require promotional materials submissions electronically in eCTD format. This affects both voluntary and mandatory submissions of promotional materials to FDA.
Start Preparing Today
Many Synchrogenix clients we work with are already submitting their promotional materials via eCTD format. Contact a Synchrogenix representative today to leverage our regulatory operations and software services to prepare yourself for this mandate.
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