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An Interview With Dr. Jonathan Genzen: Answering Your Questions About the FDA’s Final Rule on LDTs
Manage episode 439388923 series 3599669
ARUP Laboratories에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 ARUP Laboratories 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
As of September 2024, there remains enormous uncertainty about the FDA’s final rule on laboratory-developed tests (LDTs). Will it hold up in court? Which tests are subject to which requirements? How can laboratories best prepare? In this interview, Dr. Jonathan Genzen, ARUP’s chief medical officer and senior director of governmental affairs, responds to questions sent in by members of the laboratory community.
Related Information:
- ARUP Resources on the FDA’s Final Rule on Laboratory-Developed Tests (https://www.aruplab.com/fda-ldt-final-rule)
- ARUP Webinar--The FDA’s Final Rule on LDTs: What You Need To Know (https://youtu.be/nGQ3sRfWkBg)
- ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests (https://www.aruplab.com/news/05-30-2024/arup-files-declaration-support-lawsuit-challenging-fdas-rule)
- FDA email address for questions on the final rule: (ldtfinalrule@fda.hhs.gov)
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