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  1. CDER Small Business & Industry Assistance (SBIA)

FDA Electronic Drug Registration and Listing (eDRLS) using CDER Direct Training Modules

The eDRLS training modules deliver essential expertise for navigating FDA's electronic Drug Registration and Listing System.

The content provides step-by-step guidance for accurate, compliant submissions through CDER Direct. The resources combine regulatory requirements with real-world applications, featuring practical case studies and compliance frameworks that streamline your submission process.

Browse courses available on demand: 

SummaryCourse Description
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024Apply proper NDC formatting and OTC listing procedures that ensure seamless market access and operational continuity.
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023Optimize your regulatory strategy through hands-on CDER Direct demonstrations, compliance framework mastery, and interactive case studies that prevent costly market access delays and regulatory violations.
Proposed Rule on Revising the National Drug Code Format - 2022Understand the FDA's proposed rule which is intended to minimize the impact of FDA running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs to ensure continued drug identification capabilities across the healthcare system.

More about FDA's Center for Drug Evaluation and Research's (CDER) Small Business and Industry Assistance (SBIA) Program

CDER SBIA serves as the primary point of contact for pharmaceutical industry seeking to connect with the Agency. Our mission is to help you navigate FDA's extensive regulatory landscape and master human drug product regulation requirements. Learn more here or watch our video below. Find additional resources for professional development in the CDER SBIA Learn Online Training Repository. 

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