Electronic Drug Registration and Listing Using CDER Direct Virtual Conference

The free Small Business and Industry Assistance Electronic Drug Registration and Listing (eDRLs) virtual conference will provide:

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

Intended Audience

• Regulatory science and regulatory affairs professionals working on establishing registration, 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

Topics

• 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 of FDA’s registration and listing compliance program
• Describe the formats and segments of the National Drug Code (NDC)
• Discuss OTC drug listing requirements and their relation to the OTC Monograph Drug User Fee Program (OMUFA) assessment