BIO, PhRMA, others seek tweaks to FDA draft guidance on diversity in postmarketing studies

Af­ter the FDA pub­lished draft guid­ance over the sum­mer on post­mar­ket­ing ap­proach­es to col­lect­ing da­ta from un­der­rep­re­sent­ed groups, stake­hold­er groups large­ly wel­comed the FDA’s pro­pos­als and of­fered tweaks to im­prove di­ver­si­ty and in­clu­sion in the stud­ies.

The draft guid­ance, pub­lished in Au­gust, lays out the av­enues FDA us­es to de­ter­mine if it will re­quire a post­mar­ket­ing study and ex­plains con­sid­er­a­tions for post­mar­ket­ing study de­signs. The draft guid­ance is part of the agency’s con­cert­ed ef­forts in re­cent years to pri­or­i­tize di­ver­si­ty in clin­i­cal tri­als, in­clud­ing a guid­ance in April 2022 on set­ting goals for en­rolling di­verse par­tic­i­pants in tri­als.

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