Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we learn that FDA is convening its external expert group on medical device GMPs to discuss its plan to align the Quality System Regulation (QSR) with the international standard, ISO 13485:2016. We also look at the some takes on what Robert Califf will face as FDA commissioner this time around.
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