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.
“Note that although only the promotional submissions discussed in sections IV.A 95 and IV.B that fall within the scope of section 745A(a) will be required to be submitted electronically in the format specified in this guidance, firms may voluntarily choose to submit electronically other types of promotional material submissions discussed in this guidance,” FDA said.
Those two sections refer to the submission of the Form FDA 2253 and the presubmission of promotional materials for accelerated approval products.
As far as changes between the draft and final guidance, FDA said it received and considered several comments on the need to provide clarity on submission expectations and technical aspects of electronic submissions.
“A summary of changes made in this guidance include: (1) changes to provide greater clarity on submission expectations, (2) changes to provide greater clarity around technical aspects related to electronic submissions, (3) changes to create consistency between terms used in the final guidance and the eCTD guidance, (4) changes to address unexpected technical issues that have been discovered since the eCTD software launched, and (5) changes to encourage the submission of a compact disc copy of paper submissions. In addition, editorial and formatting changes were made to improve clarity,” FDA said.
Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs