FDA Lays Out Detailed Plan For Conducting Remote Facility Inspections

FDA this week released long-awaited guidance laying out the agency’s plans for tackling remote facility inspections during the COVID-19 pandemic. While one source said the guidance answers a number of significant industry questions, a lawyer noted FDA did not address how it will use remote evaluations to inspect sites that have been classified as “official action indicated.” In its Wednesday (April 14) guidance, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance...