leisure time -WSS

leisure time

author：leisure time 2025-09-30 16:14:57 - browse：45748

insulin biosimilar — The suit, filed in a Texas federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests. Jacquelyn Martin/AP

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 federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests. When the FDA finalized its test regulation plan last month, several experts said it was only a matter of time until someone in the lab industry sued.

Tests made in labs have historically gone unregulated by the FDA, as the agency considered them low-risk when it started regulating medical devices in 1976. But the tests have since become more numerous and complex, and the regulatory gray area enabled unreliable tests to thrive and harm patients. Infamous examples include Theranos’ blood tests, as well as misleading prenatal genetic tests from a range of companies.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+.

Already have an account? Log in

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Alkermes shareholders re
Next article： Analysis of telehealth claims data suggest service duplication

WSS

The future of health care in the House

Why rehabilitation engineers need to center patients in their research

Medical bills so high, Medicare adding extra digits to claim forms

Cell therapy fails to slow type 1 diabetes, but safety is established

FDA rejects Alnylam's heart disease treatment over insufficient data

BIO: Crackdown on China pharma industry would threaten U.S. drug supply

Wikipedia

leisure time

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+.

Wikipedia

Medical records are filled with copy

FDA panel signals lack of confidence in Amgen cancer drug data

Duchenne breakthrough therapy leaves behind pioneering families

Liquid biopsy for lung cancer is launched by Delfi

Hepatitis C has a cure — but many Americans still lack access to it

Cancer researcher Catriona Jamieson is sending tumors into space

Tori Bowie and the unacceptable rates of Black maternal death

Histogen: Failed biotech offers rare public look inside

Cancer drug shortages should be causing more outrage

Readout Newsletter: Biotech news, including Moderna's Covid vaccine

explore

Was Amgen transparent enough on FDA's concern on cancer drug?

FTC falls short on scrutinizing hospital mergers, study says

A virus, fished out of a lake, may have saved a man’s life

Bird flu outbreak in cows is latest avian flu curveball

In $4.8 billion deal, Bristol Myers Squibb to buy cancer player Mirati

Sana to lay off nearly a third of staff, de

hotspot

entertainment

explore

leisure time