FDA+ roundup: FDA is­sues fi­nal guid­ance on use of re­al-world ev­i­dence

The FDA pub­lished fi­nal guid­ance on Wednes­day on the use of re­al-world da­ta and re­al-world ev­i­dence in drug de­vel­op­ment to sup­port reg­u­la­to­ry de­ci­sion mak­ing.

The 12-page guid­ance lays out con­sid­er­a­tions for clin­i­cal study de­signs us­ing re­al-world da­ta (RWD) and clar­i­fies the FDA’s ex­pec­ta­tions for clin­i­cal stud­ies us­ing RWD to sup­port a reg­u­la­to­ry de­ci­sion on a drug’s safe­ty and ef­fec­tive­ness.

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