knowledge -WSS

knowledge

author：focus 2025-08-24 23:27:32 - browse：73837

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： Affirmative action in medical school literally saved lives
Next article： FDA greenlights medical device to combat bladder issues

WSS

Can U.S. cancer drug shortages be fixed?

Intellia plays down concerns on accidental germline transmission

It's time to get medical device identifiers over the finish line

A new study sees potential in DNA sequencing of infants

Leqembi, other new Alzheimer’s drugs require better biomarkers

Lecanemab for Alzheimer's is coming. Is the health system ready?

hotspot

knowledge

entertainment

Hollywood unions extend contract negotiations for actors

Wegovy improves function in certain heart failure patients

ChatGPT in medicine: STAT answers readers' burning questions

Can U.S. cancer drug shortages be fixed?

Cancer drug shortages should be causing more outrage

Petition to FDA: Get the lead out of consumer hair dyes

How one medical school became remarkably diverse

Wegovy improves function in certain heart failure patients

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

It's time to get medical device identifiers over the finish line

explore

DOJ reversal could clear way for Carroll's 1st lawsuit against Trump to proceed

A new study sees potential in DNA sequencing of infants

National associations that represent hospice owe an apology

How to make over

Health officials lay out plans to cope with respiratory virus season

What past blockbusters can tell us about future of Wegovy and other weight loss medicines

knowledge

leisure time

entertainment

entertainment