USA – FDA Finalizes Guidance on Advertising and Promotional Material Submissions

The US Food and Drug Administration (FDA) on Friday finalized guidance on the requirements and recommendations for submissions of promotional materials for prescription drugs and biological products, including the specific formats needed.

The 37-page guidance, drafted in April 2015, describes the various types of voluntary submissions (e.g., launch and non-launch submissions of draft promotional materials for comments) and required submissions of promotional labeling and advertising materials (e.g., fulfillment of the regulatory requirements for postmarketing submissions of promotional materials and submission of promotional materials for accelerated approval products).

The guidance also describes how submissions can be made using the electronic common technical document (eCTD), as well as non-eCTD and paper formats, and it features sections on content for the specific types of submissions and presentation issues.

The guidance also makes clear that in two years from the date of its issuance, “Firms will be required to submit electronically all promotional submissions that fall within the scope of section 745A(a) as specified in this guidance…