Date/Time
Date(s) - 12 Sep 2024
5:45 AM - 1:45 PM
Date: September 12, 2024
Time: 8:45 AM – 4:45 PM ET (5:45 AM – 1:45 PM AZ/PDT)
Learn More and Register
ABOUT THIS CONFERENCE (Hosted by CDER SBIA)
This annual event 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 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 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.