Scientific Integrity Policy Updates From FDA, CDC And NIH Due At White House In July
HHS-wide update will address agency integrity improvements in the wake of concerns that political considerations inappropriately influenced regulatory decisions related to COVID-19 during the Trump Administration, the General Accountability Office notes in a new report.
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Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.
Everyone but Donald Trump seems happy that the guidance is finally here, with release appearing to be driven by FDA's disclosure of advisory committee materials.
US FDA's decision to revoke the COVID-19 emergency use authorization for two anti-malarial drugs keeps with commissioner Hahn's stated goal of moving fast to tackle the pandemic, but shifting course as new data comes available. FDA cited new evidence as well as a reanalysis of the data it initially based the EUA on as reasons for pulling the authorization. Meanwhile, HHS Secretary Alex Azar appeared to equate the EUA revocation as opening the doors for broader use of the medicine, potentially undermining FDA's own communication on the drug, in yet another example of political leaders complicating the science and public health response to COVID-19.