Remodeling REMS: FDA kicks off guidance series with draft on new framework

In the first of what’s ex­pect­ed to be a se­ries of REMS-re­lat­ed ad­vice for the in­dus­try, the FDA on Mon­day un­veiled new draft guid­ance on how to im­prove the safe­ty pro­grams of­ten at­tached to high­er-risk drugs.

The 26-page draft lays out the FDA’s think­ing to help spon­sors de­sign, im­ple­ment and eval­u­ate a risk eval­u­a­tion and mit­i­ga­tion strat­e­gy, or REMS. The pro­grams can, for ex­am­ple, re­quire drug­mak­ers to de­vel­op com­mu­ni­ca­tion plans with pa­tients and doc­tors, or take oth­er steps to re­duce po­ten­tial safe­ty is­sues.

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