FDA Finally Moves to Scrutinize Specialized Health Screenings
The agency issued a rule that brings new scrutiny to a range of critical lab-developed tests, including certain cancer and ...
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Labs Developing Medical Tests Will Now Face Some FDA Scrutiny
Historically, such tests escaped federal regulation because they were considered low risk. But after the Theranos debacle, and as lab-developed tests become more complex and test for important things ...
Bird flu tests ordered for dairy cattle that cross state lines
The U.S. Department of Agriculture (USDA) has ordered bird flu tests for dairy cattle that cross state lines, it announced ...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
The Food and Drug Administration has finalized a rule to regulate medical tests that have long escaped oversight ...
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FDA issues final rule applying its medical device rules to laboratory developed tests
The Food and Drug Administration April 29 issued a final rule that would phase out its general enforcement discretion ...
US FDA tightens scrutiny of lab-developed tests with new rule
The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a new rule that ...
State health officials: 152 potentially exposed to measles after Monongalia County case
State health officials say they’re continuing to monitor for disease transmission after West Virginia’s first measles case in ...