How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of re­al-world ev­i­dence to in­form the FDA’s de­ci­sion-mak­ing con­tin­ues apace, with the agency re­leas­ing new draft guid­ance yes­ter­day on how spon­sors can com­pare …

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