definiens: rn ~ an, Iny individual . Enlily Or GovemmenLRI Body . 1.66 " PhtJ~ ' e II CII .. k / J/ T,//Jf ' means 8 human clinical trial conductoo for inclusion in ( 8) that portion of the FDA subm, ssion and approval process whteh providet for Irills of a pharmaceutical produel 011 a limited number of palients for the purposes of coll<.:<:linll dat.a on dosages . evaluating safety andIor collecting preliminary infonnalion regarding efJieacy in the proposed Indication, as more fully < kfincd in 2 ] C.F.R. § } ] 22]{b ), and ( b ) equivalent submissions .... ith s, milar requirements to the EMEA or to sim, lar Regulatory Agencies ' n o;QUfllrlC:$ in the Tnril<>ry