Lab-developed tests like prenatal screenings have become increasingly popular, all while escaping the bulk of federal scrutiny over marketing and accuracy. By Anna Clark/ProPublica Published Jun 22, ...
More than a year later, the Department of Health and Human Services (HHS) has rolled back a Trump-era policy that had limited the FDA’s oversight of lab-developed tests, or LDTs, which include a wide ...
FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing
Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that.
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same ...
(SOUTH DAKOTA SEARCHLIGHT) - A comment this week by a rural Huron farmer who’s also a lawmaker told the story of two bills affecting the cattle business. “If you have two ranchers, you’ve got four ...
People for the Ethical Treatment of Animals, a nonprofit animal rights group, have asked the National Institutes of Health and local police to investigate the death of a lab monkey at Princeton ...
ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox. After decades of intense debate and stalled ...
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