Additional clinical trial data needed for US approval of Covaxin: Bharat Biotech

additional clinical trial data needed for us approval of covaxin bharat biotech

Sumary of Additional clinical trial data needed for US approval of Covaxin: Bharat Biotech:

  • The company said USFDA didn’t reject its partner Ocugen emergency use authorisation (EUA) but recommended changing the application to a full Biologics License Applications (BLA) approval under changed circumstances..
  • “All applications have to follow the biological license application process, which is the standard process for vaccines,”…

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