02/20/2023, 787 characters
The US Food and Drug Administration (FDA) has completed a submission review of Valneva’s biologics license application for single-shot chikungunya vaccine candidate VLA1553 and determined that the application is sufficiently complete to permit a substantive review. The review classification is “priority,” Valneva says.
According to Valneva, late August 2023 has been assigned VLA1553 as the target date for the Prescription Drug User Fee Act (PDUFA) review. This is the date by which FDA intends to take action on the application. FDA approval of the submission does not imply that a license has been granted, nor does it constitute an evaluation of the adequacy of the submitted data, Valneva emphasizes.
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1. Valneva, Vienna, Credit: Valneva , (© Sender) >> Open on photaq.com
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Valneva, Vienna, Credit: Valneva, (© Aussender)
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Christine Petzwinkler
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