knowledge -WSS

knowledge

author：comprehensive 2025-09-28 23:47:54 - browse：59148

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： Trump demands the U.S. pay no more for drugs than other countries … again
Next article： Anavex keeps shifting the goalposts in its clinical trials

WSS

In same hospitals, Black patients receive fewer opioids than white patients

Methadone doses haven’t kept up in the age of fentanyl

Wife of Gilgo Beach murder suspect files for divorce, court filing shows

Why Congress must ban federal programs from using QALYs

Divers poised to search for children washed away in Pennsylvania flash flood

Police still searching for prisoner who escaped from NYC hospital

Wikipedia

knowledge

explore

Peter Hotez and the public health issue of online harassment

Emergent cuts jobs, executive role in business shake

The high cost of giving birth even with insurance

Listen: Merck v. USA, the best of ASCO, and Leqembi at the FDA

Duchenne breakthrough therapy leaves behind pioneering families

Jack Smith previously got search warrant for Trump's Twitter, new court docs show

At least 13 dead in Texas as scorching temps continue

Amylyx's ALS drug launch starts strong. It could be trouble for FDA

Affirmative action in medical school literally saved lives

American woman, child freed after being kidnapped in Haiti last month

focus

Winning ticket for $1 billion Powerball jackpot sold in California

A Q&A with Gavi’s Seth Berkley on vaccines, Covid, and more

For Cytokinetics, FDA rejection of heart drug would help, not hinder

The best solution to the drug shortages problem

Vir antibody drug aimed at influenza A fails in clinical trial

Listen: Merck v. USA, the best of ASCO, and Leqembi at the FDA

hotspot

focus

focus

focus