Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could ...
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 ...
Fierce Biotech1d
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 ...
STAT18h
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 ...
Prometheus Laboratories Launches New Anser(R) Test for Risankizumab
New Therapeutic Drug Monitoring Test for Interleukin‐23 Inhibitor SAN DIEGO, CA / ACCESS Newswire / April 1, 2025 / Prometheus Laboratories Inc. ("Prometheus"), a leader in precision-guided medicine, ...
Devdiscourse5d
Drug Alert: 47 Samples Deemed 'Not of Standard Quality'
The Central Drugs Laboratories reported that 47 drug samples were found to be 'not of standard quality.' State Drug Testing ...
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 ...
Fairmont Sentinel5d
Successful state testing could bring roadside drug tests
With a successful state-wide test on the books, the Minnesota Office of Traffic Safety (OTS) wants to install mobile drug ...
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 ...
JD Supra9d
Lab Operator Convicted in Drug-Testing Scheme
Conspiracies to rip off the Medicare system are prevalent due to the vast amounts of money flowing through the program. On February 25, Sherif ...