Tag

Laboratory Developed Tests

All articles tagged with #laboratory developed tests

health2 years ago•5 min saved

"FDA's Proposed Rule Enhances Safety and Effectiveness of Lab Developed Tests"

The U.S. Food and Drug Administration (FDA) has proposed a rule to ensure the safety and effectiveness of laboratory developed tests (LDTs), which are used in healthcare decisions. LDTs are in vitro diagnostic products used to measure substances in the body and provide information about a patient's health. The FDA is concerned that some LDTs may not provide accurate results, leading to unnecessary or delayed treatment and incorrect diagnoses. The proposed rule aims to provide greater oversight of LDTs and phase out the FDA's general enforcement discretion approach. The FDA believes this will protect public health and encourage responsible innovation in test development.

via FDA.gov|

#effectiveness #fda #health

healthcare2 years ago•3 min saved

FDA's Pilot Program Aims to Reduce Risks of Cancer Biomarker Tests.

The FDA has launched a voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. The pilot program aims to reduce the risk of using poorly performing laboratory developed tests (LDTs) for oncology drug treatment decisions. The FDA will request performance information for the tests used to enroll patients into the clinical trials that support drug approval and post the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug on the FDA website.

via FDA.gov|

#cancer-biomarkers #fda #healthcare