Animal testing requirements for monoclonal antibodies and other medications will be “reduced, refined or potentially replaced ...

This is a groundbreaking step toward advancing public health by using more effective and human-relevant methods instead of ...

Research has shed light on how a new type of antibody treatment reactivates patients' immune cells to fight ovarian cancer.

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal ...

However, the MDA is silent on laboratory tests developed by clinical laboratories for their own use or LDTs. Instead, LDTs have been regulated by CMS under CLIA. In 2021, a bill that would have ...

The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said that would raise the cost and force labs to stop creating tests that ...

The court found that the FDA rule would have negatively impacted testing on which patients and clinicians depend, and that the rule also went against Congress' intent, which is for laboratory ...

"ADLM applauds the U.S. District Court for the Eastern District of Texas for issuing a decision to vacate the Food and Drug Administration's (FDA's) final rule to regulate laboratory developed tests ...

A federal judge ruled Monday that the FDA doesn’t have the legal authority to regulate lab-developed tests, dealing a blow to the agency that has long sought to control tests in order to prevent ...

"They're also vital to ongoing innovation in laboratory medicine to meet ever-evolving clinical needs." "We remain confident in our ability to deliver the best quality tests available to our ...

From the research laboratory to the clinic, scientists increasingly seek out comprehensive workflows for the high-throughput screening and detailed analysis of antibody binding and functionality. In ...

For example, his first mini-lab contains a dynamic system such as wind that is constantly changing and reacting to external influences. It can be used to test AI tools for control problems. His second ...