The USFDA’s Game-changing Guidance on Electronic Submissions for Promotional Materials and Grouped Submissions
In April 2022, the United States Food and Drug Administration (US FDA) took a significant stride toward modernizing the Regulatory process by releasing guidance on the electronic submission of promotional materials for human prescription drugs. The guidance, titled “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs,” outlines the requirements for electronic submissions and highlights the benefits they offer.