WCG FDAnews Announces: The Return of VALID Webinar on May 17, 2023

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WCG FDAnews

May 10, 2023, 00:00 ET

The pandemic has resulted in increased scrutiny from policymakers and patient advocacy groups on FDA regulatory policy for vaccines, diagnostic testing, particularly lab-developed tests (LDT), and in vitro diagnostics (IVD).

FALLS CHURCH, Va., May 10, 2023 /PRNewswire-PRWeb/ -- In this webinar, medical device manufacturers will be updated on the current IVD and LDT regulatory landscape and potential implications of the Verifying Accurate Leading-edge IVCT Development Act (VALID Act).

Michael M. Gaba, FDA Practice vice chair, Colleen Faddick, Health Care Operations Practice chair, and Christopher C. Rorick, senior policy advisor from the Public Policy Practice Group at Polsinelli, will explain why there is significant interest in further regulating these diagnostic mechanisms beyond what the FDA currently has in place via the Clinical Laboratory Improvement Amendments (CLIA) and medical device policy, and the implications for ensuring adequate clinical validation if the VALID Act becomes law.

Webinar attendees will:

  • Understand the current CLIA framework and LDTs
  • Comprehend the FDA regulation of IVD tests as medical devices and their regulatory stance towards LDTs
  • Understand the history and development of the VALID Act and the framework to define and regulate in vitro clinical tests (IVCT)
  • Learn the legislative pathways and prospects for the VALID Act to become law and FDA implementation timelines
  • Gain clarity on what it means for a test to have adequate clinical validation
  • Recognize the business implications for labs that have historically built their models around the development of LDTs

Webinar Details
The Return of VALID:
What the Future Holds for IVDs and LDTs
An FDAnews Webinar
Wednesday, May 17, 2023, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/the-return-of-valid

Tuition:
$287

Easy Ways to Order:
Online: https://wcg.swoogo.com/the-return-of-valid
By phone: 888.838.5578 or 703.538.7600

About WCG FDAnews:
WCG FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on WCG FDAnews' newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations. Learn more at fdanews.com.

Media Contact

Michelle Butler, WCG FDAnews, 703.538.7665, [email protected]

SOURCE WCG FDAnews