Odosek Lab Solutions Expands Mobile DNA Testing Services in Columbia, South Carolina
Columbia, SC, April 03, 2025 (GLOBE NEWSWIRE) -- Odosek Lab Solutions announced today the expansion of its mobile DNA and ...
Judge foils FDA plan to regulate lab-developed tests
The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...
American Hospital Association1d
Court strikes down FDA rule on regulating lab-developed tests
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have ...
Federal Court 'Vacates in Its Entirety' the FDA's Costly and Onerous Lab Test Rule
RFK Jr. should accept the ruling and instruct the agency to immediately halt all efforts to regulate laboratory-developed and ...
MedTech Dive2d
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...
Yahoo Finance3d
DDL Launches New GMP Lab for Drug-Delivery Testing
and material testing services, is pleased to announce the opening of a new Good Manufacturing Practice (GMP) laboratory dedicated to drug-device combination product testing. This expansion ...
FDA Lacks Authority to Regulate Laboratory Tests, Judge Rules
A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to ...
Fierce Biotech2d
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
STAT1d
Texas judge strikes down FDA’s plan to regulate lab-developed tests
The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...