How The US FDA Finds Pre-Approval Inspection Alternatives During COVID-19 Pandemic
Officials explain how remote record reviews, site transfers and other factors can green-light approvals of drugs and biologics.
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If agency has concerns about facilities it cannot inspect, it will generally issue complete responses, Q&A guidance says.
Agency resuming domestic inspections with the help of a pandemic rating system to identify localities where inspections will be safest for investigators and plant workers. Another safety factor: all inspections will be pre-announced.