Litigation against the FDA's Final Rule on lab-developed tests (LDTs) is causing uncertainty to rise as the US regulator gears up for a legal clash with the lab industry. Since the FDA revealed its ...
AUSTIN, Texas--(BUSINESS WIRE)--Many clinical laboratories are now under the gun to achieve Phase One compliance with the Food and Drug Administration’s (FDA) LDT rule before the May 2025 deadline.
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Dublin, May 21, 2024 (GLOBE NEWSWIRE) -- The "U.S. Laboratory Developed Tests (LDTs) Market - Focused Insights 2024-2029" report has been added to ResearchAndMarkets.com's offering. In alignment with ...
Prominent stakeholders have written to a top Republican lawmaker in response to an inquiry into the regulation of diagnostic tests, including laboratory-developed tests (LDTs). While the stakeholders ...