eSubmission of Promotional Labeling and Advertising Materials via the eCTD FDA Gateway : The Time Has Come for Advertising and Promotion to Submit in Module One.

In June 2019, the Food and Drug Administration (FDA) issued its final Guidance on submission of advertising and promotional materials to the Office of Prescription Drug Promotion (OPDP) in eCTD format through the electronic gateway. Our goal was to put in place a stepwise plan and clear process to submit these materials in advance of June 2021 when electronic submissions become mandatory. The first step was to test every submission type and every possible iteration, therefore, as issues arose, problems could be easily addressed and resolved.