FDA lays out post­mar­ket­ing ap­proach­es for da­ta col­lec­tion from un­der­rep­re­sent­ed groups

The FDA on Thurs­day pub­lished draft guid­ance on con­sid­er­a­tions for post­mar­ket stud­ies on pop­u­la­tions that were un­der­rep­re­sent­ed in pre­mar­ket tri­als.

The agency tells spon­sors to …

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