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See today's BioWorld MedTechSee today's BioWorld
Home » FDA’s Hahn emphasizes regulatory flexibility, but FDA not ‘walking away’ from RCTs
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FDA’s Hahn emphasizes regulatory flexibility, but FDA not ‘walking away’ from RCTs

June 1, 2020
By Mark McCarty
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
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