Platinum-Free Systemic Therapy in First-Line Metastatic Urothelial Carcinoma: Mirage or Oasis in the Platinum Desert? Cancer predictive or diagnostic assays, offered as Laboratory-Developed Tests ...

The FDA, concerned about potential harm to patients, sought increased oversight of these products by classifying them as medical devices. This change was prudent, the FDA argued, due to the growing ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products" to specify that such definition "[includes] when the ...

A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean ...

The Centers for Medicare and Medicaid Services, one of the federal bodies that regulates laboratory blood tests, sent the company a letter released on Wednesday -; which was uploaded by The Verge–that ...

In November 1999, the Institute of Medicine (IOM) published a pro.found article entitled "To Err Is Human: Building a Safer Health System." The very first line of the publication reads, "Health care ...