Email Trove From US FDA Shows Peter Marks As Champion For Plasma Authorization
The emergency use authorization for convalescent plasma in August 2020 on weak data from an expanded access program has largely been viewed as a politically charged decision by the Trump administration. But newly revealed emails from the run up to the decision indicate Center for Biologics Evaluation and Research Director Peter Marks backed the plan.
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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.
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The request for an interview by the House Select Subcommittee on the Coronavirus Crisis seeks more information on the actions by President Trump and others to influence FDA decisions on HCQ, convalescent plasma, and vaccine decisions.