Bharat Biotech has said it'll carry out clinical trials in US to support Covaxin's marketing application in the country. It didn't disclose details regarding possible number of participants or whether it'd be a local bridging trial. Earlier, Bharat Biotech's US partner, Ocugen, said it'd pursue a Biologics License Application path, a "full approval" mechanism by FDA for drugs and vaccines.
Bharat Biotech has said it'll carry out clinical trials in US to support Covaxin's marketing application in the country. It didn't disclose details regarding possible number of participants or whether it'd be a local bridging trial. Earlier, Bharat Biotech's US partner, Ocugen, said it'd pursue a Biologics License Application path, a "full approval" mechanism by FDA for drugs and vaccines.
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