FDA really helpful that Ocugen “pursue a Biologics Licence Application (BLA) submission instead of an EUA application” and “requested additional information and data”. Ocugen anticipates that knowledge from extra scientific trials might be wanted to help the submission. “We were close to finalising our EUA application when we received (FDA’s) recommendation to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” stated Ocugen’s Shankar Musunuri. businesses
FDA denies emergency use nod for Covaxin in US – ET HealthWorld
New Delhi: The US Food and Drug administration has denied approval for emergency use of Bharat Biotech’s Covaxin, and has requested for extra knowledge, biopharmaceutical Ocugen, the US accomplice of the Indian vaccine maker has stated.
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Sunday, June 13, 2021
Total confirmed cases
Updated on June 13, 2021 1:58 pm