knowledge -WSS

knowledge

author：entertainment 2025-09-02 22:22:34 - browse：2

empty test tubes in the hand. -- first opinion coverage from STAT — Adobe

The Food and Drug Administration on Friday announced its intention to start regulating tests developed in laboratories — closing the “Theranos loophole” that has allowed inaccurate tests to slip through the cracks.

Lawmakers came close last year to passing a bill that would have given the FDA this authority, but it was ultimately rejected by Republicans who sympathized with the labs in academic medical centers and hospitals that opposed the provision. FDA Commissioner Robert Califf said at the time that if the bill failed, the agency would take matters into its own hands.

The proposed rule fulfills that promise, adding lab diagnostics to the list of devices that fall under FDA enforcement — a move that patient groups and non-lab test makers support, and that laboratories are likely to dispute. When the FDA started regulating medical devices in 1976, lab-developed tests were simple and offered mostly to local patient populations. The agency generally allowed labs to use these tests without submitting proof of their efficacy.

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

Subscribe Log In

Previous article： BioMarin wins approval for gene therapy to treat hemophilia A
Next article： Readout Newsletter: Merck, Vertex, and Viking updates

hotspot

knowledge

WSS

Adam's Biotech Scorecard: A closer look at Viking Therapeutics, PDS Biotech

Washington mulls new rules to avert another Change Healthcare

Eisai exec who led development of Alzheimer’s drug to retire

Why the world’s most expensive drug might be worth the price

Eliminate the waiting period for sterilization covered by Medicaid

Accuser who called Kevin Spacey 'vile sexual predator' admits he joked about incident

leisure time

knowledge

hotspot

Activists slam private health insurers over coverage restrictions

Pandemic and All Hazards Preparedness Act needs lean update

Continuity nursing helped my family in our darkest PICU moments

Washington mulls new rules to avert another Change Healthcare

Affirmative action in medical school literally saved lives

Adam's Biotech Scorecard: A closer look at Viking Therapeutics, PDS Biotech

New air purifier tech could be key to improving indoor air quality

Primary care physicians play key roles in Alzheimer's management

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

FDA's naming rule on biosimilars has undermined competition

hotspot

Teachers share how revamped forgiveness program helped with their student loans

Oprah kicked off a national conversation on obesity. Let's have it

Biden’s NIH nominee is languishing in Congress

Eisai exec who led development of Alzheimer’s drug to retire

FDA's naming rule on biosimilars has undermined competition

Adam's Biotech Scorecard: A closer look at Viking Therapeutics, PDS Biotech

hotspot

knowledge

focus

focus