definiens: shall have the lRClIIling 5CI forth in Sccrion 53(b ) . I, I J. ~FDA " means the Uniled Slates Food and Drug AdminiSlrlltion ( or ilS soocc : aor agenoo;y ) and/or ! he COITCSpOIIdmg govcmmenbll or other authoriry in IlflOI / Ia ' country, IS applicable, such as the European Agency for the Evalualion of Medicinal Products ( or ) in Europe 1.12 . ~FDA ActM : an~ tl > c Un, ted State : ! ! FedenJ Food, Drug and CoImetil : Act ( 21 U.S, C, ) 01, II . ~rq, ), alld tl > c regulauuns promUlgated thereunder, as amended from time to time, and any suCCC5S0r statute(s )