Joe Lennerz: A pivotal moment in the ongoing debate over FDA’s regulation of LDTs
Joe Lennerz, Chief Scientific Officer at Boston Gene, shared a post on LinkedIn:
“The U.S. Department of Justice has submitted its closing brief in the Association for Molecular Pathology (AMP)and American Clinical Laboratory Association against the FDA, marking a pivotal moment in the ongoing debate over FDA’s regulation of laboratory-developed tests (LDTs).
The decision, expected soon, will reshape the regulatory landscape for labs, manufacturers, and patients.
Key takeaways:
1) Labs may face stricter compliance requirements, potentially impacting innovation.
2) FDA oversight aims to enhance test reliability but raises concerns about reduced test availability.
3) The ruling could establish significant legal precedents on FDA’s jurisdiction and the interplay of FDCA and CLIA.
Please consider reading my breakdown and personal thoughts on this pivotal document.
While the scientific evidence on the rule’s impact remains inconclusive,oral arguments could help provide the judge with the critical context tonavigate this complex issue.
A balanced consensus is vital to protect public health while fostering innovative.”
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