How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drug­mak­ers look­ing to de­sign a new reg­istry or use an ex­ist­ing one to sup­port a reg­u­la­to­ry de­ci­sion on a drug’s ef­fec­tive­ness or safe­ty will need …

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