Analytics tool plays key role in helping agency oversee quality of 1,800 newly registered hand sanitizer facilities despite travel restrictions.

Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.

Manufacturers should expect that remote audits of suppliers may take longer than onsite ones until they get more familiar with these audits; it is also important to abide by data confidentiality rules and take frequent breaks when conducting these audits, says Rx-360 CEO.