FDA issues guidance for industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs

Today, the FDA published the guidance for industry entitled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The guidance describes various types of regulatory submissions of promotional materials that firms submit to the FDA along with specific recommendations for the content and format for submission in paper copy and electronic format, including how to submit promotional materials electronically.

Under Section 745A(a) of the FD&C Act, no sooner than 24 months after this guidance is issued, the FDA will require that specific promotional materials be submitted to the FDA in electronic format. While only promotional submissions that fall under section 745A(a) will be required to be submitted electronically, the FDA encourages firms to submit other types of promotional materials electronically as well.  Questions related to the content and format of eCTD submissions to the FDA’s Office of Prescription Drug promotion may be sent to OPDPeCTD@fda.hhs.gov.

This guidance finalizes the draft guidance published in April 2015. 

Find additional information in the Federal Register Notice.