The US Food and Drug Administration has approved more than a dozen product submissions using alternative tools in place of site inspections that would normally be a condition of approval but are difficult or impossible to conduct during the COVID-19 pandemic.
Agency officials have been carefully reviewing whether and how to conduct pre-approval inspections for the steady stream of drug applications that continue to arrive at the agency during the
Officials with the agency’s Office of Pharmaceutical Quality explained during a recent Parenteral Drug Association webinar on virtual inspections how they are going