Similar Stories to Us Fda Publishes Final Rule For Laboratory Developed Tests on Bing News

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Mon, 04/29/2024 - 6:59am

US FDA publishes final rule for laboratory developed tests

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Children's Hospitals Brace for Reduced Test Access, Higher Costs Under LDT Final Rule
Pathology directors expect that they will be unable to send out or receive samples for new tests when the FDA's new LDT rule takes effect.
06/3/2024 - 7:16 am | View Link
ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests
ARUP Laboratories is backing a federal lawsuit filed by the American Clinical Laboratory Association (ACLA) challenging the FDA's final rule to regulate laboratory-developed tests (LDTs) as medical ...
06/2/2024 - 5:00 pm | View Link
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests
On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of ...
06/2/2024 - 1:00 pm | View Link
Clinical lab industry sues to block FDA's new oversight of lab-developed tests
ACLA said the agency overstepped when it announced it would regulate all in vitro diagnostics with the same approach it uses for medical devices.
05/31/2024 - 4:04 am | View Link
ACLA Files First Lawsuit Attempting to Block FDA’s Final Rule on LDTs
The first entities to sue the agency over the final rule, the American Clinical Laboratory Association (ACLA) and PCR lab HealthTrackRx, filed their lawsuit in the US District Court for the Eastern ...
05/30/2024 - 1:00 pm | View Link
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