The United States (US) Food and Drug Administration (FDA) have finalised their guidance on the requirements and recommendations for submissions of promotional materials for human prescription drugs and biological products. The FDA stated that they received and considered multiple comments on the need to provide clarity on submission expectations and the technical features of electronic submissions.
The guidance, which was drafted back in April 2015, details the types of voluntary submissions and required submissions of promotional labelling and advertising materials. For example, fulfilment of the regulatory requirements for post-marketing submissions of promotional materials and submission of promotional materials for accelerated approval products. Further information regarding how submissions can be made using the electronic common technical document (eCTD), as well as non-eCTD and paper formats, is also outlined in the guidance.
The FDA have noted 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”. Sections IV.A 95 and IV.B refer to the submission of the Form FDA 2253 and the pre-submission of promotional materials for accelerated approval products.
A summary of the changes made in the FDA’s guidance include:
- “changes to provide greater clarity on submission expectations;
- changes to provide greater clarity around technical aspects related to electronic submissions
- changes to create consistency between terms used in the final guidance and the eCTD guidance;
- changes to address unexpected technical issues that have been discovered since the eCTD software launched, and
- changes to encourage the submission of a compact disc copy of paper submissions”.
To read FDA’s guidance on providing regulatory submissions in electronic and non-electronic format – promotional labelling and advertising materials for human prescription drugs, please click here.