FDA drafts guid­ance on demon­strat­ing sub­stan­tial ev­i­dence of ef­fec­tive­ness

The FDA on Thurs­day is­sued draft guid­ance on demon­strat­ing “sub­stan­tial ev­i­dence” of ef­fec­tive­ness for drugs and bi­o­log­ics, ex­pand­ing on decades-old guid­ance is­sued to ad­dress …

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