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 statu­to­ry changes brought on by the Food and Drug Ad­min­is­tra­tion Mod­ern­iza­tion Act of 1997 (FDAMA).

Specif­i­cal­ly, the 18-page draft guid­ance builds on the FDA’s 1998 guid­ance Pro­vid­ing Clin­i­cal Ev­i­dence of Ef­fec­tive­ness for Hu­man Drug and Bi­o­log­i­cal Prod­ucts, which de­tailed the FDA’s ex­pec­ta­tions for ev­i­dence to sup­port the ap­proval of new drugs and bi­o­log­ics or ap­pli­ca­tions for sup­ple­men­tal in­di­ca­tions in light of FDAMA’s clar­i­fi­ca­tion that a sin­gle ad­e­quate and well-con­trolled clin­i­cal tri­al and con­fir­ma­to­ry ev­i­dence can be used to sup­port ap­proval.

While the FDA says its “stan­dard for demon­strat­ing ef­fec­tive­ness has not changed” since the 1998 guid­ance, the agency says that new guid­ance is nec­es­sary to keep up with sci­en­tif­ic ad­vance­ments and changes in drug de­vel­op­ment over the last two decades.

sorry couldn’t copy the link here!