US FDA is studying which inspections it can skip in fiscal year 2018 now that it has recognized the inspectorates of eight European countries under a mutual recognition agreement with the EU, Alonza Cruse, who directs the agency's Office of Pharmaceutical Quality Operations, told a Food and Drug Law Institute meeting in Washington, DC.
FDA Mulls Which EU Inspections To Skip Under EU MRA
As US FDA sets its FY 2018 inspection priorities, it is considering whether there are recent or upcoming inspections by inspectorates in eight European countries recognized under a US/EU mutual recognition agreement that it could rely on instead, agency official says. Over time, FDA could rely more on EU inspection priorities.
