Biologics license application
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A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:
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Ocugen to seek full approval for Covaxin in US via BLA instead of EUABharat Biotech’s US partner Ocugen has dropped its plans of applying for an emergency use authorisation (EUA) for indigenously developed Covaxin and will be pursuing the biologics license application..IndiaTimes - Published | |
Ocugen to take BLA route for Covaxin in US based on FDA recommendation; seek emergency use nod for CanadaBharat Biotech’s US partner Ocugen has dropped its plans of applying for an emergency use authorisation (EUA) for indigenously developed Covaxin and will be pursuing the biologics license application..IndiaTimes - Published |
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