The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc.’s emergency authorization request for the company’s COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc.’s vaccine for those aged 6 months through 4 years.
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Ocugen Inc. said on May 23 the U.S. drug regulator has lifted the clinical hold on a mid-to-late stage trial of the COVID-19 vaccine being developed by the company’s Indian partner Bharat Biotech.
As organizations continue to evaluate and implement automation and AI technology, it is important to consider how increased use of technology should align with both industry best practices and regulations – and to proactively address how technology adoption will impact stakeholders involved in routine pharmacovigilance activities while ensuring deployment and implementation poses no risk to breaching guidelines or regulations.