FDA ad­dress­es bio­phar­ma's di­ver­si­ty prob­lem with new draft guid­ance

Back in 2020 — as drug­mak­ers strug­gled to en­roll di­verse pop­u­la­tions in Covid-19 tri­als — the FDA re­leased new guid­ance urg­ing phar­ma com­pa­nies to de­vise a plan for mak­ing their stud­ies more in­clu­sive. In its lat­est draft guid­ance, the agency is fill­ing in more of the de­tails.

The FDA pro­vid­ed a draft frame­work on Wednes­day for drug­mak­ers and med­ical de­vice man­u­fac­tur­ers re­gard­ing plans to en­roll more di­verse tri­al par­tic­i­pants. Part of that frame­work in­cludes set­ting goals for en­roll­ment and spec­i­fy­ing re­ten­tion strate­gies, such as pro­vid­ing lan­guage as­sis­tance and re­duc­ing the bur­dens of par­tic­i­pa­tion with tools like tele­health.

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