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Agenda

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ABOUT THIS EVENT

This conference is intended to provide basic instruction in the registration and listing policy and process for those who are new to this regulatory program as well as offer regulatory professionals more in-depth information on issues and current events affecting Drug Registration and Listing. FDA will provide:

• 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

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals working on establishment registration and drug listing submissions and data compliance.
• Consultants focused on 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 COVERED

• Explaining the latest proposed rule on the National Drug Code (NDC).
• Learning about the current automated validation rules for registration and listing submissions.
• Providing accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.

LEARNING OBJECTIVES

• Explain who must register and list.
• Provide an overview to FDA’s registration and listing compliance program.
• Explain how the strength conversion is calculated in listing SPLs.
• Describe the formats and segments of the National Drug Code (NDC).

FDA RESOURCES

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