鑳¤偛蹇楀崥澹浘鏄疐DA鐨勫緥甯堬紝鍚屾椂涔熸槸FDA鍖荤枟鍣ㄦ閮ㄩ棬鐨勮祫娣卞璇勫畼鍛橈紝浠庣瀛︿笓涓氥佺洃绠$粡楠屽強娉曞緥璁ょ煡鐨勪笁閲嶈搴︿笂涓篎DA鎻愪緵寤鸿鍜屾敮鎸併傚湪FDA灏嗚繎10骞寸殑宸ヤ綔涓紝闄や簡瀹℃壒杩囨暟鐧句釜浜у搧澶栵紝浠栬繕鍔╁姏FDA澶氫釜鏀跨瓥鍒跺畾浠ュ強涓庝笟鐣岃В鍐崇籂绾风殑妗堜緥銆
“褰撲紒涓氫笉婊DA鐨勮瘎瀹″喅绛栨椂锛屽彲浠ラ氳繃璇夎鏉ョ淮鎶よ嚜韬潈鐩婏紝杩欐槸瀵笷DA鏉冨姏鐨勪竴绉嶅埗琛°傝櫧鐒禙DA鎷掔粷浣犳椂鍙兘鏈変笂鍗冪鐞嗙敱锛屼絾FDA骞朵笉浼氭晠鎰忓垇闅炬垨鎷掓壒鏂拌嵂锛涗竴浜涘浗鍐呬紒涓氶潰瀵笷DA鐨勬嫆缁濅細鎸佹湁涓绉嶄笉鍙煡璁烘垨闃磋皨璁猴紝杩欐槸涓嶅彲鍙栫殑銆”鑳¤偛蹇楄銆
浣滀负浠h〃FDA鐨勫緥甯堬紝鑳¤偛蹇楅鍏堥渶瑕佹繁鍏ョ爺绌跺拰鐞嗚ВFDA鎵绠¤緰鐨勬硶寰嬫硶瑙勶紝鍥犳浠栫簿閫氥婄編鍥借仈閭﹂鍝併佽嵂鍝佸拰鍖栧鍝佹硶妗堛嬪強鍏朵慨姝f锛屼互鍙婁笌椋熷搧銆佽嵂鍝併佸尰鐤楀櫒姊扮瓑鐩稿叧鐨勬硶寰嬫潯鏂囥傚叾娆★紝褰揊DA闈复澶嶆潅鐨勭洃绠¢棶棰樻椂锛屼粬浼氭彁渚涗笓涓氱殑娉曞緥寤鸿锛屽府鍔〧DA鍋氬嚭姝g‘鐨勫喅绛栥
鍙備笌FDA涓庡巶鍟嗙殑娉曞緥璇夎鍜屼簤璁В鍐筹紝鏄儭鑲插織鏃跺父瑕侀潰瀵圭殑鎯呮櫙銆傚綋FDA鐨勫喅绛栨垨琛屼负鍙楀埌琛屼笟璐ㄧ枒鏃讹紝浠栦細绉瀬涓篎DA杩涜杈╂姢銆備粬闇瑕佺啛鎮夋硶寰嬭瘔璁肩▼搴忥紝鎺屾彙杈╄鎶宸э紝浠ョ‘淇滷DA鐨勬潈鐩婂緱鍒板厖鍒嗕繚鎶ゃ
杈冩棭鎺ュ彈瑗挎柟鏂囧寲鏁欒偛鐨勮儭鑲插織娣辫皺缇庡浗鏀挎不浣撶郴銆
涓庝骇涓氬姹傚叡璇嗗寲瑙e垎姝
璋堝埌浠h〃FDA鍙備笌娉曞緥璇夎鍜屼簤璁В鍐筹紝鑳¤偛蹇楄锛孎DA涓庡埗鑽涓氳櫧鍦ㄧ洃绠′笌琚洃绠$殑灞傞潰锛屽湪鍒╃泭涓婂瓨鍦ㄥ樊寮傦紝浣嗘湰璐ㄤ笂閮芥槸涓轰簡浜虹被鍋ュ悍浜嬩笟骞惰偐浣滄垬鍚屼竴涓垬澹曢噷鐨勬垬鍙嬨傚湪缇庡浗涓氱晫鏅亶楂樿柂鐨勬儏鍐典笅锛孎DA澶ч儴鍒嗗畼鍛橀兘鏄负浜嗛珮灏氱殑鐞嗙敱鎵嶆効鎰忛暱鏈熶换鑱屼簬鑱旈偊鏀垮簻銆傚洜姝わ紝璇夎鍜屼簤璁苟闈濬DA涓庝紒涓氫箣闂村簲鏈夌殑姝e父鍏崇郴銆傚湪浜夎涓姹傚叡璇嗐佸寲瑙e垎姝э紝鎵嶆槸鍙屾柟搴旀寔鐨勬纭佸害銆
鍦ㄦ瀬绔儏鍐典笅锛屼紒涓氭寫鎴楩DA鐨勫喅绛栧苟涓嶇綍瑙併備负浜嗗簲瀵规绫绘儏鍐碉紝FDA鐗瑰埆璁剧珛浜嗕笓闂ㄧ殑閫氶亾锛屽苟鍒跺畾浜嗙浉搴旀寚鍗椼“姣曠珶锛屼竴浜涗紒涓氬巻缁忓骞寸殑澶3鏈熶复搴婅瘯楠岋紝鎶曞叆浜嗗ぇ閲忕殑浜哄姏鐗╁姏锛屽鏋淔DA鎷掔粷鎵瑰噯锛屽浠讳綍浼佷笟鑰岃█閮芥槸闅句互鎵垮彈鐨勬墦鍑汇傚湪缇庡浗锛屽緢澶氫紒涓氫細閫夋嫨閫氳繃璇夎鏉ヨ川鐤慒DA鐨勫鎵瑰喅瀹氥”浠栬銆
FDA鍐呴儴鏂拌嵂鐨勬壒鍑嗘潈鍔涘線寰闆嗕腑鍦ㄥ涓讳换鎵嬩腑銆傚綋浼佷笟涓嶆弧瀹や富浠荤殑鍐崇瓥鏃讹紝浠栦滑閫氬父浼氶夋嫨灏嗘浜嬩笂鎶ヨ嚦鏇撮珮灞傜骇銆傛鏃讹紝楂樺眰涓讳换浼氳姹備笅灞炲強涓嬪睘鐨勪笅灞炶缁嗛槓杩颁笉鎵瑰噯鐨勭悊鐢憋紝骞跺彲鑳藉彫寮涓撳浼氳锛屼互瑙e喅浼佷笟鐨勭枒铏戙
鐒惰岋紝鑳¤偛蹇楃瑧瑷锛屽湪浠栧鐞嗙殑浼楀妗堜緥涓紝浼佷笟鎴愬姛鎸戞垬FDA绉戝鎬х殑鎯呭喌鏋佷负缃曡銆傝繖鏄洜涓猴紝FDA鐨勫璇勫憳寰寰鑳借皟鍔ㄥ绉嶅鏍风殑璇佹嵁鍜岀悊鐢辨潵鍧氬畾鏀寔鑷繁鐨勫喅绛栥傛濡傚父瑷鎵璇达紝“濡傛灉FDA鎷掔粷鎵瑰噯浣狅紝瀹冭兘鎵惧嚭涓婂崈涓悊鐢便傚叾瀹烇紝鑻ュFDA鐨勫喅绛栦綋绯诲拰璇夋眰鏈夋繁鍏ヤ簡瑙g殑璇濓紝鎵瑰噯涓嶉氳繃鐨勫師鍥犲線寰閮芥槸鍙互鎵惧埌鐨勩FDA鐨勫喅绛栧苟涓嶆槸涓涓粦绠憋紝娌¢偅涔堢绉樸”鑳¤偛蹇楄銆
FDA骞朵笉浼氭晠鎰忓垇闅炬垨鎷掔粷鎵瑰噯鏂拌嵂锛涙湁鏃讹紝涓浜涘浗鍐呬紒涓氶潰瀵笷DA鐨勫喅绛栦細鎸佹湁涓绉嶄笉鍙煡璁烘垨闃磋皨璁猴紝杩欐槸涓嶅彲鍙栫殑銆傝儭鑲插織濡傛槸璇淬
涓嶈繃锛岃儭鑲插織骞朵笉鍙嶅浼佷笟绉瀬鎻愬嚭涓婅瘔銆傚洜涓轰笂璇夎繃绋嬩负浼佷笟鎻愪緵浜嗙敵杈╃殑鏈轰細锛屽苟鍙兘鑾峰緱瀹濊吹鐨勫缓璁紝鏈夊姪浜庝紒涓氳繘涓姝ュ畬鍠勭绾垮拰浜у搧寮鍙戠瓥鐣ャ傚悓鏃讹紝璇夎杩囩▼瀹為檯涓婁篃鏄疐DA鑷垜瀹¤鍜屾彁鍗囧喅绛栦弗璋ㄦх殑鏈轰細锛岃繖绉嶅弽鎬濇満鍒舵湁鍔╀簬FDA涓嶆柇瀹屽杽鍏剁洃绠′綋绯汇
涓轰簡閬垮厤璧板埌涓婅瘔杩欎竴姝ワ紝浠栧缓璁紒涓氬湪鏃╂湡鐮斿彂闃舵灏变笌FDA杩涜鍏呭垎浜ゆ祦銆傚湪姣忎釜鐜妭涓紝浼佷笟闇瑕佷弗鏍兼寜鐓DA鐨勬寚寮曡繘琛屾搷浣滐紝纭繚鐮斿彂宸ヤ綔鐨勫悎瑙勬с傝繖鏍蜂竴鏉ワ紝浼佷笟灏辫兘澶уぇ闄嶄綆琚嫆缁濇壒鍑嗙殑椋庨櫓銆
“璇夎骞堕潪瑙e喅浜夎鐨勫敮涓閫斿緞銆侳DA榧撳姳浼佷笟閫氳繃鍗忓晢鍜屽悎浣滄潵瑙e喅闂锛屼互淇冭繘FDA涓庝紒涓氫箣闂寸殑鐞嗚В鍜屼俊浠伙紝鍏卞悓鎺ㄥ姩琛屼笟鐨勫垱鏂般” 鑳¤偛蹇楄銆
FDA鏄繁灞傛斂娌讳綋鍒剁殑浣撶幇
浠嬬粛瀹岃嚜宸辩殑鏇惧湪缇庡浗FDA浣滀负杈╂姢寰嬪笀鐨勪富瑕佸伐浣滐紝浠栭噸鏂板洖婧簡FDA杩欎竴鐧惧勾鐩戠鏈烘瀯璁剧珛鐨勮儗鏅拰浣垮懡銆備粬璇村埌锛孎DA鍦ㄥ鎵规柊鑽殑杩囩▼涓紝鏃㈡嫢鏈夋潈鍔涳紝涔熸壙鎷呯潃璐d换銆傚叾鏉冨姏浣撶幇鍦ㄥ鎵规柊鑽椂鎵嬫彙鐢熸潃澶ф潈锛岃矗浠诲垯鍦ㄤ簬纭繚鎵瑰噯涓婂競鐨勮嵂鐗╁畨鍏ㄦ湁鏁堬紝浠ュ強琚編鍥藉叾浠栨斂娌绘垨闈炴斂娌诲洟浣撳鏂圭洃鐫c
杩欏潎婧愯嚜缇庡浗鐨勬斂娌讳綋鍒讹紝鑳¤偛蹇楄繘涓姝ュ垎鏋愰亾銆
浣滀负涓涓笁鏉冨垎绔嬪浗瀹讹紝缇庡浗鐨勬斂娌讳綋绯绘棬鍦ㄧ‘淇濆悇鏉冪殑鍐崇瓥鍜岃涓哄彈鍒版湁鏁堢殑鍒剁害涓庡钩琛°“杩欎竴浣撳埗鐨勬牳蹇冨湪浜庡皢琛屾斂銆佺珛娉曞拰鍙告硶涓夊ぇ鏉冨姏鍒嗗埆璧嬩簣涓嶅悓鐨勬満鏋勶紝浣垮畠浠浉浜掔嫭绔嬪張鐩镐簰鍒惰 銆”鑰孎DA鍜岃繖涓夊ぇ鏉冨姏閮芥湁鍏崇郴銆傜畝鍗曟潵璇达紝涓庡叾浠栫殑鑱旈偊鏈烘瀯绫讳技锛孎DA鏄竴涓浗浼氳祴鏉冦佺櫧瀹墽琛岋紝骞跺彈鏈楂樻硶闄㈢洃鐫g殑杩欐牱涓涓斂娌绘満鏋勩
浣滀负涓涓浉瀵圭嫭绔嬬殑鐩戠鏈烘瀯锛孎DA寮哄ぇ鐨勮鏀跨洃绠℃潈鍔涙潵婧愪簬鍥戒細閫氳繃鐨勬硶寰嬫硶瑙勶紝鍥犳杩欎簺琛屾斂鏉冧篃甯歌绔嬫硶鏉冨拰鍙告硶鏉冪洃鐫e拰鍒惰 銆侳DA鐨勫法澶ф潈鍔涳紝鍙湁寤虹珛鍦ㄤ弗璋ㄧ瀛︾殑鍩虹涔嬩笂鎵嶈兘婊¤冻绔嬫硶鏉冪殑瑕佹眰銆傝繖浜涙潈鍔涚殑琛屼娇锛岀敱涓鎵逛笓涓氱殑銆佺粡杩囦弗鏍奸夋嫈鐨勮嵂鍝佸拰鍣ㄦ瀹¤瘎浜哄憳璐熻矗銆備粬浠牴鎹渶鏂扮殑涓村簥鏁版嵁锛屽埗瀹氫笌鑽搧銆佸尰鐤楀櫒姊般佸寲濡嗗搧绛夌浉鍏崇殑娉曞緥銆佹潯娆俱佸埗搴﹀拰鎸囧崡銆
鍙︿竴鏂归潰锛孎DA骞朵笉鏄竴涓函绮圭殑绉戝鏈烘瀯銆傝儭鑲插織璁や负锛孎DA鐨勮鏀垮喅绛栬繃绋嬮渶涓ユ牸閬靛惊鍥戒細璁剧珛鐨勬硶寰嬫鏋讹紝涔熻閬靛惊娉曢櫌瀵圭珛娉曟潈鐨勮В閲婂拰瀵硅鏀挎潈鐨勭洃鐫c傚洜姝わ紝FDA鍚屾椂涔熸槸涓涓斂娌绘満鏋勩傛瘮鏂硅锛岃鏀挎硶涓婄殑涓涓牳蹇冨噯鍒機hevron Deference鍦ㄨВ鍐虫秹鍙婅鏀挎満鍏宠В閲婃硶寰嬬殑闂鏃惰捣鍒颁簡鍏抽敭浣滅敤锛岃繖涓師鍒欐潵鑷簬1984骞存渶楂樻硶闄㈢殑涓涓粡鍏稿垽渚——Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc銆
Chevron Deference鍘熷垯鍙嶆槧浜嗘硶闄㈠琛屾斂鏈哄叧鍦ㄥ叾涓撲笟棰嗗煙鍐呯殑涓撲笟鍒ゆ柇鐨勫皧閲嶏紝涔熸槸FDA寮哄ぇ鑷垜瑙h鏉冪殑鐢辨潵銆侰hevron Deference鏃繚璇佷簡FDA鐨勭伒娲绘у拰涓撲笟鎬э紝鍙堜负娉曢櫌鎻愪緵浜嗘竻鏅扮殑瑁佸喅妗嗘灦銆傜劧鑰岋紝鍦ㄤ弗鏍肩殑娉曞緥妗嗘灦涓嬶紝FDA鍗磋兘灏嗗叾绉戝鎬т笌娉曞緥鎬у畬缇庣粨鍚堬紝“杩欐槸FDA鐨勪竴澶х壒鐐广”鑳¤偛蹇楄銆
鍦‵DA锛屾瘡涓椤瑰喅绛栦笉鍏夎缁忚繃娣卞叆鐨勭瀛︾爺绌朵互纭繚鍏剁瀛︽э紝杩樺繀椤绘弧瓒宠仈閭﹁鏀挎硶锛岄氳繃涓ユ牸鐨勫鏌ョ▼搴忓強鍏紑閫忔槑鐨勮璁烘墠鑳界‘淇濆喅绛栫殑姝e綋鎬э紙due process锛夈傚叾绉戝鎬у拰姝e綋鎬х殑缁撳悎锛屼綋鐜板湪涓庡埗鑽涓氱爺鍙戜汉鍛樻繁鍏ユ矡閫氫笌鍗氬紙鍚庢墍褰㈡垚鐨凢DA鎶鏈寚鍗楋紙FDA Guidance锛変箣涓傝繖浜涙寚鍗椾负鑽墿鐨勭爺鍙戞彁渚涗簡鏄庣‘鐨勬柟鍚戯紝鏈夊姪浜庡噺灏戠爺鍙戣繃绋嬩腑鐨勪笉纭畾鎬с
鍖荤枟鍣ㄦ瀹¤瘎鍌敓RWE
闄や簡浣滀负杈╂姢寰嬪笀锛岃儭鑲插織鏈寮濮嬪姞鍏DA鏃讹紝鏇炬姇韬簬鍖荤枟鍣ㄦ閮ㄩ棬銆備粬鐢“鐙傞噹鐨勮タ閮”鏉ュ舰瀹瑰櫒姊板璇勭殑鎰熷彈锛屽洜涓哄櫒姊扮绫荤箒澶氾紝澶у皬涓嶄竴锛屼笉鍍忚嵂鍝侀偅鏍峰叿鏈夊緢寮虹殑鍊熼壌鎬с傝嵂鍝佸璇勯儴闂ㄩ棿鍗忎綔绱у瘑锛屾瘡浣嶄笓瀹堕兘鑳藉湪鑷繁鐨勯鍩熻揪鍒版繁鍘氱殑瀛︽湳閫犺銆傝屽櫒姊颁骇鍝佺殑瀹¤瘎鍒欐洿涓哄鏉傦紝姣忎釜浜у搧鐨勬爣鍑嗗悇寮傦紝鍥犳鐏垫椿鎬ф洿澶с
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