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FDA Declines to Review Modernas mRNA-1010 Flu Vaccine Application, Citing Comparator Concerns The FDAs Center for Biologics Evaluation and Research (CBER) has declined to review Modernas biologics license application (BLA) for its investigational influenza vaccine, mRNA-1010, and issued a refusal-to-file (RTF) letter, according to an announcement released by the company

They are a regulated, legal category of prescription medication prepared under the 503A and 503B regulatory framework by state-licensed compounding pharmacies, subject to USP standards

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