Electronic Drug Registration and Listing (eDRLS) Using CDER Direct

September 12, 2024

About This Course

This annual event provides:

• A demonstration on how-to submit establishment registration and drug listing data using CDER Direct.
• An overview on registration and listing regulatory requirements and compliance framework.
• Case studies for an interactive learning experience at the end of the day.

Topics Covered

• Explaining the proposed rule on the National Drug Code (NDC) format.
• Providing accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.
• Discussing drug amount reporting requirements.

Learning Objectives

• Explain who must register and list.
• Provide an overview to FDA’s registration and listing compliance program.
• Describe the formats and segments of the National Drug Code (NDC).
• Discuss OTC drug listing requirements and its relation to OTC Monograph Drug User Fee Program (OMUFA) assessment.

Intended Audience

• Regulatory science and regulatory affairs professionals working on establishment registration and drug listing submissions and data compliance.
• Consultants and vendors assisting industry with Structured Product Labeling (SPL) submissions to FDA.
• Healthcare professionals using drug listing data and downstream databases to access prescribing and labeling information.
• Foreign drug manufacturers and importers that manufacture and import drugs for US commercial distribution.

Resources

• Federal Register Revising the National Drug Code Format and Drug Label Barcode Requirements
• Electronic Registration and Listing Instructions
• FDA Direct
• Strength Conversion in Drug Listing
• Structured Product Labeling Resources

visit the FDA.gov webpage