25
May
Ocugen, Bharat Biotech's American partner for COVID-19 vaccine Covaxin, has submitted a "Master File" to the US Food and Drug Administration prior to seeking an emergency use authorization in that country. Ocugen has submitted key information and data to date including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies as a Master File for FDA review and input prior to a planned EUA submission. "We are currently waiting for additional data from Bharat Biotech from the ongoing Phase 3 clinical trial for a EUA submission. Due to the current surge in COVID-19 cases in India, this process is taking…
