The US Food and Drug Administration (FDA) has conducted more than 20 remote regulatory assessments (RRAs) of manufacturing facilities through its preapproval inspection (PAI) program and hopes to use this remote method more for assessing low-risk facilities, said Derek Smith, deputy director of the Office of Pharmaceutical Manufacturing Assessment (OPMA) in the Office of Pharmaceutical Quality (OPQ) at the 11 April Generic Drug Forum (GDF), which was held virtually and onsite in Bethesda, MD.
 
Smith and Rakhi Shah, associate director of OPMA, addressed some triggers for PAIs as well as Generic Drug User Fee Amendments (GDUFA III) commitments related to facility evaluations...[RAPS]