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CBER
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FDA swiftly reverses RTF decision on Moderna flu shot candidate
The regulator is allowing the pharma giant’s revised biologics licensed application to proceed to review.
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RTF flu vaccine letter heard around the world
The FDA issued an extremely rare refuse-to-file letter related to Moderna’s new mRNA flu vaccine.
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FDA issues warning letters to four companies for sale of HIV self-collection blood tests
The federal regulator contends the four biologics firms lack appropriate testing and marketing authorization.