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 ...
Fierce Biotech15h
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 ...
American Hospital Association10h
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 ...
MedTech Dive14h
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 ...
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 ...
Endpoints News20h
Fed­er­al judge nix­es FDA's lab-de­vel­oped test rule, says it ex­ceed­ed agen­cy's au­thor­i­ty
The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s ...
Testing AI in the mini-lab
“The mini-labs provide a flexible test environment that delivers real measurement data,” Gamella said in a statement.
Health First's four Brevard hospitals earn reaccreditation for laboratory operations
Inspectors evaluate every aspect of a laboratory’s operations, from testing procedures and equipment maintenance to ...