Update on GMP Inspections by US FDA

摘要

Janet Woodcock, Acting Commissioner of the US Food and Drug Administration (FDA), provides an update on the FDA's inspection activity during the COVID-19 pandem ic, including what new tools the agency has used for inspections, which has included a mix of mission-critical, on-site inspections and remote record reviews. What does she recommend as the next steps in returning to more normal inspection operations?