The FDA is preparing testing and manufacturing guidelines for a quick review of Omicron-targeted vaccines and drugs, if they are needed
The Food and Drug Administration is laying the groundwork for the rapid review ofif they turn out to be needed, according to people familiar with the matter.
The agency, building on rules established earlier this year to assess shots and treatments, has been meeting with drugmakers and setting guidelines for the studies and data needed to swiftly evaluate products targeting the new Omicron Covid-19 variant, the people said.
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