Webinar: FDA Oversight of LDTs: The Present and Future Regulatory Landscape

Friday, October 8, 2021 | 12 p.m. CT/1 p.m. ET

Presented by

Charles Dunham, Shareholder at Greenberg Traurig, LLP

Tyler Scandalios, Associate at Greenberg Traurig, LLP

This webinar will provide an update on the current status of FDA oversight of laboratory developed tests (LDTs) and insights on the pending legislation in Congress and proposed changes by the Biden Administration that may impact how LDTs and test kits are regulated by the FDA. This presentation will provide valuable insights to both independent and institutional laboratories seeking to understand strategic planning to optimize market success and maintain compliance.

Learning Objectives

  • Understand the Food and Drug Administration’s (FDA’s) legal basis for its regulation of laboratory-developed tests (LDTs).
  • Understand the current state of the FDA’s regulation of LDTs, how it has evolved over time, and how it may change in the future.
  • Come away with insights into how laboratory strategic planning efforts can address the current status of FDA’s regulation of LDTs and potential future developments.

Continuing Education

  • 1.0 Contact Hour

Pricing

  • Included with Professional Membership (including Entry and Group members)
  • $29 for Emeritus Members
  • $49 for Non-Members

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