<code id='B2F5827D28'></code><style id='B2F5827D28'></style>
    • <acronym id='B2F5827D28'></acronym>
      <center id='B2F5827D28'><center id='B2F5827D28'><tfoot id='B2F5827D28'></tfoot></center><abbr id='B2F5827D28'><dir id='B2F5827D28'><tfoot id='B2F5827D28'></tfoot><noframes id='B2F5827D28'>

    • <optgroup id='B2F5827D28'><strike id='B2F5827D28'><sup id='B2F5827D28'></sup></strike><code id='B2F5827D28'></code></optgroup>
        1. <b id='B2F5827D28'><label id='B2F5827D28'><select id='B2F5827D28'><dt id='B2F5827D28'><span id='B2F5827D28'></span></dt></select></label></b><u id='B2F5827D28'></u>
          <i id='B2F5827D28'><strike id='B2F5827D28'><tt id='B2F5827D28'><pre id='B2F5827D28'></pre></tt></strike></i>

          focus

          focus

          author:explore    Page View:459
          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

          explore

          What does generative AI mean for health care? We asked experts
          What does generative AI mean for health care? We asked experts

          MikeReddyforSTATHealthcarecompaniesareracingtoincorporategenerativeAItoolsintotheirproductpipelinesa

          read more
          Senate committee scrutinizes Medicare Advantage brokers
          Senate committee scrutinizes Medicare Advantage brokers

          Sen.RonWyden(D-Ore.)DrewAngerer/GettyImagesSenateFinanceCommitteemembersfrombothpartiestookaimWednes

          read more
          DIEP, the 'gold standard' of breast reconstruction, is under threat
          DIEP, the 'gold standard' of breast reconstruction, is under threat

          AdobeIn1983,Iflewhomefromcollegetobewithmymotherasshewokeupfromamastectomy.Sheoptedoutofbreastrecons

          read more

          Medicare reduced heart disease by changing how it pays doctors

          AdobeWASHINGTON—DoctorsloweredtheincidenceofheartdiseaseandstrokesamongtheirpatientswhenMedicarerewa