FDA NextGen Submission Portal Guide
FDA has published its Electronic Submission Gateway NextGen Unified Submission Portal Guide for Industry Users, outlining the functionalities, processes, and requirements for submitting regulatory information through the NextGen Unified Submission Portal (USP). The document says it is intended to facilitate a smooth transition to Electronic Submission Gateway NextGen, providing users with clear instructions, troubleshooting steps, and best practices.
The Unified Submission Portal is described as a Web-based interface that is the primary platform for preparing, submitting, and managing electronic regulatory submissions to FDA.
The guide says key portal features are a guided submission process, submission management, and security and compliance.
The document includes an Introduction, Getting Started with USP, User Registration and Access, USP System Navigation, Submissions Via USP, Tracking Submissions, User Management, User Support and Troubleshooting, Additional Training Resources, and two Appendices.