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 do their best to as­sem­ble rep­re­sen­ta­tive pop­u­la­tions in pre­mar­ket stud­ies, but un­der­stands that they may face chal­lenges in do­ing so. The draft guid­ance lays out the av­enues FDA us­es to de­ter­mine if it will re­quire a post­mar­ket­ing study and it lays out con­sid­er­a­tions for post­mar­ket­ing study de­signs.

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