The U.S. Food & Drug Administration (FDA) issued a guidance on providing regulatory submissions in electronic and non-electronic format. This guidance pertains to submissions of promotional materials for human prescription drugs to the FDA made by manufacturers, packers, and distributors, whether the applicant or an entity acting on behalf of the applicant. Specifically, this guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER). This guidance also explains certain aspects of electronic submission of promotional materials in module 1 of the electronic common technical document (eCTD).
When updating product licence details, there are always areas in the variation submission processes which can cause validation issues or the generation of Notification with Grounds (NWG) letters, ultimately resulting in a rejection or delay. These can be time consuming for the MAH (Marketing Authorisation Holder) and may impact on assessment timeframes.
Learn about the key themes and "show stoppers" which have emerged over the last 5 years in this post by the Medicines and Healthcare Products Regulatory Agency.