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Policy recommendations We have applauded the announcement of more no-warning international manufacturing inspections, and for 503Bs, we suggest the following: Inspect every 503B within two months of registration Theres no such thing as a pop up 503B. It doesnt make sense to allow 503Bs to make drug products when other manufacturers in our system must have an inspection before shipping medicine

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Diabetologia 62 , 20792087 (2019)