<code id='D0ECED8F28'></code><style id='D0ECED8F28'></style>
    • <acronym id='D0ECED8F28'></acronym>
      <center id='D0ECED8F28'><center id='D0ECED8F28'><tfoot id='D0ECED8F28'></tfoot></center><abbr id='D0ECED8F28'><dir id='D0ECED8F28'><tfoot id='D0ECED8F28'></tfoot><noframes id='D0ECED8F28'>

    • <optgroup id='D0ECED8F28'><strike id='D0ECED8F28'><sup id='D0ECED8F28'></sup></strike><code id='D0ECED8F28'></code></optgroup>
        1. <b id='D0ECED8F28'><label id='D0ECED8F28'><select id='D0ECED8F28'><dt id='D0ECED8F28'><span id='D0ECED8F28'></span></dt></select></label></b><u id='D0ECED8F28'></u>
          <i id='D0ECED8F28'><strike id='D0ECED8F28'><tt id='D0ECED8F28'><pre id='D0ECED8F28'></pre></tt></strike></i>

          focus

          focus

          author:comprehensive    Page View:15328
          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. 

          advertisement

          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

          comprehensive

          United colonoscopy coverage change 'may cost lives,' doctors say
          United colonoscopy coverage change 'may cost lives,' doctors say

          AdobeWhengastroenterologistslearnedinMarchthatUnitedHealthcareplanstobarricademanycolonoscopiesbehin

          read more
          Better Therapeutics data on benefit with GLP
          Better Therapeutics data on benefit with GLP

          APStockYou’rereadingthewebeditionofSTAT’sHealthTechnewsletter,ourguidetohowtechnologyistransformingt

          read more
          In Memoriam: Notable people who died in 2023
          In Memoriam: Notable people who died in 2023

          1:29AlanArkinattendsthe26thAnnualScreenActorsGuildAwardsatTheShrineAuditoriumonJan.19,2020inLosAngel

          read more

          NIH fellows want a pay raise. Will that mean less money for grants?

          NIHresearchfellowswanttounionize,inlargepartbecausetheywantaraise.Willthatmeanlessmoneyforgrants?Lyd