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The FDA said it won’t review Moderna’s flu vaccine application, a surprise decision that the company is describing as a shifting of the standards for its pivotal trial well after it thought it had reached an agreement.
Monday’s action by the agency is one of the harshest steps it can take on an application. In an unusual disclosure of what are typically confidential communications between companies and the regulator, Moderna published the refuse-to-file letter that was signed by vaccines and biologics chief Vinay Prasad.
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