Key FDA Drug and Device Updates Wednesday, April 21, 2021 Over the past month, there have been a significant number of developments affecting FDA-regulated companies. This GT Alert provides an update on key FDA personnel changes; on final regulations governing software that are exempt from FDA-regulation as a result of the 21st Century Cures Act (Pub. L. 114-255); and on a new FDA policy related to drug facility inspections. In addition, there are other announcements regarding medical devices and the regulation of certain personal protection equipment (PPE). Personnel at FDA Dr. Patrizia Cavazzoni appointed director of the Center for Drug Evaluation and Research (CDER).