The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency’s “toolbelt.”
So asserted Patrizia Cavazzoni, director of FDA’s Center for Drugs Evaluation and Research (CDER) who discussed how some of the agency’s learnings during the pandemic will be applied going forward at the agency’s annual Regulatory Education for Industry conference on Monday.
“We have really seen an expansion of the utilization of [digital health] technologies as an essential tool to allow for greater use of decentralized clinical trials which are very important during the pandemic,” Cavazzoni said…
