Popular Science

Scores of critical lab tests fall into a regulatory void. The FDA is trying to close it.

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, ...
STAT

Another suit filed against FDA over lab-developed test rule

Lizzy led STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. A ...
STAT

Clinical lab trade group sues FDA over plan to regulate lab-developed tests

A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...
JD Supra

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.
MM&M

Scores of critical lab tests fall into a regulatory void. The FDA is trying to close it.

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 ...