ARTICLE | Regulation
Despite lack of controlled data, FDA authorizes use of hydroxychloroquine and chloroquine for COVID-19
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March 30, 2020 5:05 AM UTC
Updated on Mar 31, 2020 at 1:08 AM UTC
FDA Sunday granted an Emergency Use Authorization for the use of hydroxychloroquine and chloroquine to treat COVID-19, laying the agency open to the charge that it is prioritizing President Donald Trump’s hope over its usual requirements for rigorous data.
The authorization markedly lowers the threshold for the quantity and rigor of data required for approval. FDA has rarely if ever approved a drug solely on anecdotal data with no demonstration of its safety or efficacy for its intended use...