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Introduction
The FDA Electronic Drug Registration and Listing (eDRLS) training modules are resources designed to provide essential expertise for navigating FDA's electronic Drug Registration and Listing System. These modules offer step-by-step guidance for accurate and compliant submissions through CDER Direct, combining regulatory requirements with practical, real-world applications.
Target Audience
- Pharmaceutical industry requiring guidance on drug registration and listing procedures
- Industry personnel responsible for NDC formatting, OTC listing procedures, and regulatory submissions
- Professionals looking to optimize their regulatory strategy and ensure market access compliance
Key Benefits
- Guidance on proper NDC formatting and OTC listing procedures to ensure seamless market access and operational continuity
- Hands-on CDER Direct demonstrations that provide practical experience with the submission system
- Case studies that illustrate real-world applications and regulatory scenarios
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