The FDA has defended its decision to issue a refusal-to-file (RTF) letter for Moderna's new mRNA-based influenza vaccine, claiming the company had not used an appropriate control group in its pivotal ...

Moderna has accused the FDA of moving the goal posts and being inconsistent with earlier advice. The FDA has refused to accept Moderna's marketing application of an mRNA-based seasonal influenza ...

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Correspondence to Dr Thomas Bandholm, Dept of Clinical Research, Copenhagen University Hospital, Amager and Hvidovre, Hvidovre DK-2650, Denmark; thomas.quaade.bandholm{at}regionh.dk The REPORT guide ...