FDA: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024

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Date/Time
Date(s) - 12 Sep 2024
5:45 AM - 1:45 PM

Location


Date: September 12, 2024
Time: 8:45 AM – 4:45 PM ET (5:45 AM – 1:45 PM AZ/PDT)
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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.