When can ob­ser­va­tion­al stud­ies sup­port a drug's ef­fec­tive­ness? FDA ex­plains in new draft guid­ance

The FDA on Wednes­day re­leased high­ly-an­tic­i­pat­ed draft guid­ance on when drug spon­sors can use ob­ser­va­tion­al stud­ies to help demon­strate a drug’s ef­fec­tive­ness, for the first …

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