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1950s`@NIH CRC & ƒ{ƒ‰ƒ“ƒ^ƒŠ[‚Ȑݒu
1961 @ƒTƒŠƒhƒ}ƒCƒh
1962 @Kefauver-Harris C³–@
@@@@ @@EIND@E2 RCTs@@ EIC
1972 @ƒ^ƒXƒL[ƒMŽ–Œ
1974 @‘‰ÆŒ¤‹†–@@@@@@@@ EIRB
1979 @ƒxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg@@ EŽOŒ´‘¥
1981¨1991 @45CFR46u”팱ŽÒ‚Ì•ÛŒìv
@@@@@@@@@@ @@@@ 21CFR50, 56, (54, 600, 312, 812)
1990s @ƒvƒ‹ƒgƒjƒEƒ€l‘ÌŽÀŒ±ƒXƒN[ƒv
@@@@@@ ‘æ‡T‘ŠŽŽŒ±‚ÌŽ€–S—á