knowledge -WSS

knowledge

author：focus 2025-09-27 13:03:05 - browse：34642

Photo illustration of Covid 19 testing swabs on a blue background. — Timothy Stenzel led the FDA's diagnostics division during the Covid-19 pandemic, as the agency scrambled to push through and validate accurate Covid tests. Adobe

Timothy Stenzel, the federal regulator who led the Food and Drug Administration’s diagnostics division during the chaotic time of Covid-19 pandemic, has left the agency. The FDA confirmed Thursday that Stenzel, who led the FDA’s office of in vitro diagnostics, retired at the end of 2023.

During the early days of the pandemic, Stenzel was in the middle of a turf battle between the Centers for Disease Control and Prevention and the FDA over the regulation of Covid tests. At one point, the CDC made Stenzel wait at its facility overnight after he arrived for a meeting on Covid test development, Politico reported at the time.

It was a hectic time. Testmakers rapidly introduced new Covid-19 screening products with little data, as it was a brand new virus. The pandemic especially laid bare FDA’s inability to control lab-developed tests (LDTs). Many of the Covid-19 PCR tests fell in this category. Early on, using powers granted by the public health emergency, the FDA required labs to apply for emergency use authorization. But a STAT investigation found that the Department of Health and Human Services told the FDA to stop this measure, despite knowing that many of the tests may have been inaccurate.

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

Subscribe Log In

Previous article： FDA approval of Sarepta Duchenne genetic therapy gives me hope
Next article： A Q&A with the global head of Boehringer Ingelheim's innovation unit

focus

WSS

Stroke deaths set to near 10 million globally by 2050

Phenylephrine and the overlooked value of the placebo effect

Stroke deaths set to near 10 million globally by 2050

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

Phenylephrine and the overlooked value of the placebo effect

Analysis of telehealth claims data suggest service duplication

focus

knowledge

leisure time

As demand for Covid shots wanes, Moderna seeks its next success

FDA panel signals lack of confidence in Amgen cancer drug data

Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies

Sana to lay off nearly a third of staff, de

How to save PrEP access — and even expand it

When women are denied an abortion, their children fare worse than peers

Alkermes shareholders re

AI can decode, harness the power of the humane immune system

FDA approval of Sarepta Duchenne genetic therapy gives me hope

Colorectal cancer study finds potential in overlooked immune cell

hotspot

FDA panel signals lack of confidence in Amgen cancer drug data

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

Phenylephrine and the overlooked value of the placebo effect

FDA panel signals lack of confidence in Amgen cancer drug data

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

FDA rejects Alnylam's heart disease treatment over insufficient data

explore

focus

focus

entertainment