The 37-paged guideline, which was drafted back in April 2015, has been finalized by the Food and Drug Administration (FDA) in the U.S. The guidelines focus on Promotional material submission for biological product and prescription drugs. Along with that, other voluntary submissions such as non-launch and launch submissions of promotional materials for comments were also taken into consideration.

Further description of specific formats for postmarketing and submission of promotional materials has also been amended. The submission can be done by eCTD and non-eCTD formats. The guidelines have also made it clear that the promotional submission should comply with section 745(a) and must be processed electronically.