COVID-19 Vaccine Developers Don’t Need Pre-Approval Inspections for Emergency Use

By Sam | November 5, 2020

The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER).
Source: Drug GMP Report

Posted in Drug GMP Report