FDA Issues Draft Guidance for Industry on Electronic and Non-Electronic Submissions of Promotional Materials for Human Prescription Drugs and Biologic Products?

FDA announced the availability of the draft guidance “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” that explains how manufacturers, packers, and distributors (firms) that may either be the applicant or acting on behalf of the applicant should make submissions pertaining to promotional materials for human prescription drugs and biologic products (“drugs”) to the FDA. Specifically, the draft guidance explains how to submit promotional materials using module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file, and aligns with the release of Module 1 Specifications v2.3, allowing CDER to accept submissions pertaining to promotional materials.

This draft guidance includes both binding and nonbinding provisions related to the submission of promotional materials. Therefore, certain promotional material-related submissions will be required to be submitted in electronic format, beginning no earlier than 24 months after this guidance is issued in final form. The guidance also describes the various types and methods of submissions of promotional materials to the Agency that will not be required to be submitted electronically.

While FDA has yet to launch the version of module 1, which will be able to accept promotional material submissions to CDER, the Agency expects to launch in the near future. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications v2.3 within the 3rd Quarter of FY 2015, and will provide 30 days advance notice to industry via the eCTD web page. FDA is also encouraging people who plan to provide submissions using the eCTD specifications to work with them closely and submit samples for validation.