FDA main­tains Covid flex­i­bil­i­ties for IRB re­view of ex­pand­ed ac­cess drugs for in­di­vid­u­als

The FDA in­di­cat­ed that it will main­tain some pan­dem­ic-era flex­i­bil­i­ties in in­sti­tu­tion­al re­view board (IRB) as­sess­ments of ex­pand­ed ac­cess drugs for in­di­vid­ual pa­tients in im­me­di­ate­ly-in-ef­fect guid­ance pub­lished Fri­day.

The FDA ex­plains in the eight-page guid­ance that ex­pand­ed ac­cess drugs refers to in­ves­ti­ga­tion­al drugs that serve the main pur­pose of treat­ing, di­ag­nos­ing or mon­i­tor­ing a pa­tient’s dis­ease as op­posed to glean­ing in­for­ma­tion about the drug, which is gen­er­al­ly the main pur­pose of a clin­i­cal tri­al.

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Cambridge, MA, USA