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锟斤拷之锟斤拷医锟斤拷锟轿斤拷锟斤拷锟斤拷式签约锟斤拷锟斤拷锟斤拷医锟斤拷医院
锟斤拷锟斤拷锟斤拷锟秸ｏ拷锟斤拷锟秸讹拷锟斤拷时!锟斤拷喜迎锟斤拷锟斤拷99锟斤拷锟斤拷
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锟斤拷锟斤拷锟斤拷锟斤拷色锟斤拷锟斤拷锟斤拷强锟狡碉拷陆锟叫癸拷锟斤拷锟斤拷驻锟斤拷锟斤拷锟斤拷医锟斤拷医院
2015锟斤拷6锟斤拷28锟秸ｏ拷锟斤拷锟斤拷全锟斤拷锟斤拷锟斤拷前锟斤拷锟斤拷锟斤拷锟斤拷系
锟斤拷锟斤拷锟斤拷祝锟斤拷院锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟揭皆猴拷锟斤拷医锟斤拷协锟斤拷锟斤拷位锟斤拷锟斤拷锟斤拷医锟剿撅拷锟杰匡拷锟斤拷
为锟结彻锟斤拷实锟斤拷锟斤拷医锟侥撅拷锟今、硷拷强医院锟斤拷暮锟斤拷锟?/p>
锟角达拷锟斤拷锟斤拷锟斤拷锟斤拷系统锟斤拷锟绞伙拷锟斤拷锟斤拷锟斤拷锟饺斤拷锟斤拷锟剿ｏ拷锟斤拷医锟斤拷医院锟斤拷士锟斤拷锟斤拷锟?/h2>
锟斤拷锟斤拷锟斤拷锟斤拷3锟姐，锟斤拷锟斤拷锟斤拷医锟斤拷医院5.12锟斤拷锟绞伙拷士
锟斤拷锟斤拷锟矫碉拷锟叫匡拷医院
锟斤拷锟矫的诧拷锟斤拷锟斤拷锟较凤拷展锟斤拷医学也锟节诧拷锟较地斤拷锟斤拷锟斤拷
FDA锟斤拷证
锟斤拷锟斤拷FDA锟斤拷证
锟斤拷锟斤拷锟斤拷锟斤拷食品锟斤拷药锟斤拷锟斤拷锟斤拷锟?Food and Drug Administration)锟斤拷锟紽DA锟斤拷FDA 锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟节斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟?(DHHS) 锟酵癸拷锟斤拷锟斤拷锟斤拷锟斤拷 (PHS) 锟斤拷锟斤拷锟斤拷锟斤拷执锟叫伙拷锟斤拷之一锟斤拷锟斤拷为一锟揭匡拷学锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷FDA 锟斤拷职锟斤拷锟斤拷确锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷诘锟绞称凤拷锟斤拷锟阶逼凤拷锟揭╋拷铩拷锟斤拷锟斤拷萍锟斤拷锟揭斤拷锟斤拷璞革拷头锟斤拷锟斤拷品锟侥帮拷全锟斤拷锟斤拷锟斤拷锟斤拷锟皆憋拷锟斤拷锟斤拷锟斤拷锟斤拷为锟斤拷要职锟杰碉拷锟斤拷锟斤拷锟斤拷锟街伙拷锟?/p>
锟斤拷锟斤拷锟矫伙拷锟斤拷锟斤拷每一位锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷疃枷⑾拷锟截★拷锟斤拷锟较ｏ拷FDA锟斤拷锟斤拷锟斤拷为锟斤拷锟斤拷锟斤拷锟较碉拷食品锟斤拷药锟斤拷锟斤拷锟斤拷锟斤拷锟街伙拷锟斤拷锟斤拷锟斤拷锟斤拷喽纪拷锟窖帮拷锟酵斤拷锟斤拷 FDA 锟侥帮拷锟斤拷锟斤拷锟劫斤拷锟斤拷锟斤拷锟斤拷锟矫癸拷锟斤拷品锟侥帮拷全锟斤拷
锟斤拷锟斤拷食品锟斤拷药锟斤拷锟斤拷锟斤拷锟?FDA)锟斤拷锟杰ｏ拷食品锟斤拷药品(锟斤拷锟斤拷锟斤拷药)锟斤拷医锟斤拷锟斤拷械锟斤拷食品锟斤拷锟接硷拷锟斤拷锟斤拷妆品锟斤拷锟斤拷锟斤拷食品锟斤拷药品锟斤拷锟狡撅拷锟斤拷锟斤拷锟斤拷锟斤拷7%锟斤拷锟斤拷锟窖撅拷锟斤拷锟斤拷锟皆硷拷锟斤拷锟接诧拷品锟侥监督锟斤拷锟斤拷;也锟斤拷锟斤拷锟斤拷妆品锟斤拷锟叫凤拷锟斤拷牟锟狡凤拷锟斤拷锟较诧拷品锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷全锟叫关的碉拷锟接诧拷品锟斤拷医锟狡诧拷品锟斤拷锟斤拷品锟斤拷使锟矫伙拷锟斤拷锟窖癸拷锟斤拷锟叫诧拷锟斤拷锟斤拷锟斤拷锟接★拷锟斤拷锟斤拷锟接凤拷锟斤拷影锟斤拷锟斤拷锟洁健锟斤拷锟酵帮拷全锟斤拷目锟侥诧拷锟皆★拷锟斤拷锟斤拷统锟街わ拷锟斤拷锟斤拷莨娑拷锟斤拷锟斤拷锟斤拷锟狡凤拷锟斤拷刖拷锟紽DA锟斤拷锟斤拷证锟斤拷锟斤拷全锟襟，凤拷锟斤拷锟斤拷锟叫筹拷锟斤拷锟斤拷锟桔★拷FDA锟斤拷权锟斤拷锟斤拷锟斤拷锟斤拷锟揭斤拷锟斤拷锟接察、锟斤拷权锟斤拷违锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷摺锟斤拷锟斤拷菁锟杰的诧拷同锟斤拷品锟斤拷围锟斤拷锟缴凤拷为锟斤拷锟铰硷拷锟斤拷锟斤拷要锟斤拷芑锟斤拷锟斤拷锟?/p>
锟斤拷锟斤拷1锟斤拷食品锟斤拷全锟斤拷实锟斤拷营锟斤拷(CFSAN):
锟斤拷锟斤拷锟斤拷锟斤拷FDA锟斤拷锟斤拷锟斤拷锟侥诧拷锟脚★拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟脚┮碉拷锟斤拷锟较斤拷锟斤拷锟斤拷唷拷锟斤拷菁锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷全锟斤拷锟斤拷锟斤拷食品锟斤拷全锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷食品锟斤拷应锟斤拷全锟侥ｏ拷锟斤拷锟角ｏ拷每锟疥还锟斤拷锟叫达拷约锟斤拷锟斤拷千锟斤拷锟斤拷锟斤拷食源锟皆硷拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷十锟斤拷锟斤拷锟斤拷千锟斤拷锟斤拷食源锟皆硷拷锟斤拷锟斤拷要住院锟斤拷锟狡ｏ拷锟斤拷千锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷食源锟皆硷拷锟斤拷锟斤拷食品锟斤拷全锟斤拷营锟斤拷锟斤拷锟斤拷锟节硷拷锟斤拷食源锟皆硷拷锟斤拷锟斤拷锟劫斤拷食品锟斤拷全锟斤拷锟斤拷锟劫斤拷锟斤拷锟街计伙拷锟斤拷锟界：HACCP锟狡伙拷锟斤拷锟狡癸拷实施锟饺★拷
锟斤拷锟斤拷锟矫碉拷职锟杰帮拷锟斤拷锟斤拷确锟斤拷锟斤拷食品锟斤拷锟斤拷锟接碉拷锟斤拷锟绞硷拷色锟截的帮拷全;确锟斤拷通锟斤拷锟斤拷锟斤工锟秸匡拷锟斤拷锟斤拷食品锟斤拷锟斤拷锟较的帮拷全;锟斤拷锟斤拷锟斤拷锟斤拷确锟斤拷识食品(锟斤拷煞帧锟接拷锟斤拷锟斤拷锟斤拷锟斤拷锟?锟酵伙拷妆品锟斤拷锟斤拷墓锟斤拷锟斤拷疃?锟狡讹拷锟斤拷应锟斤拷锟斤拷锟竭和凤拷锟芥，锟皆癸拷锟斤拷锟斤拷食锟斤拷锟斤拷锟斤拷锟接わ拷锟绞筹拷锟斤拷浞斤拷锟揭斤拷锟绞称?确锟斤拷锟斤拷妆品锟缴分硷拷锟斤拷品锟侥帮拷全锟斤拷确锟斤拷锟斤拷确锟斤拷识;锟洁督锟酵规范食品锟斤拷业锟斤拷锟桔猴拷锟斤拷为;锟斤拷锟斤拷锟斤拷锟斤拷锟竭斤拷锟斤拷锟斤拷锟斤拷为锟斤拷展;锟斤拷锟捷和地凤拷锟斤拷锟斤拷锟侥猴拷锟斤拷锟斤拷目;协锟斤拷食品锟斤拷准锟酵帮拷全锟饺★拷
锟斤拷锟斤拷2锟斤拷药品锟斤拷锟斤拷锟斤拷锟叫撅拷(CDER):
锟斤拷锟斤拷锟斤拷旨锟斤拷确锟斤拷锟斤拷锟斤拷药锟酵非达拷锟斤拷药锟侥帮拷全锟斤拷锟斤拷效锟斤拷锟斤拷锟斤拷药锟斤拷锟斤拷前锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷喽斤拷谐锟斤拷锟斤拷锟斤拷鄣锟揭伙拷锟斤拷锟斤拷锟揭┢凤拷锟饺凤拷锟斤拷锟狡凤拷锟斤拷悴伙拷细锟斤拷碌谋锟阶硷拷锟酵憋拷锟斤拷没锟斤拷锟杰碉拷锟接★拷锟姐播锟皆硷拷锟斤拷锟斤拷锟斤拷锟较碉拷药品锟侥癸拷锟斤拷锟斤拷实锟皆★拷锟较革拷锟斤拷药品锟斤拷锟结供锟斤拷锟斤拷锟斤拷锟斤拷准确锟斤拷全锟斤拷锟斤拷息锟斤拷
锟斤拷锟斤拷3锟斤拷锟借备锟斤拷全锟酵凤拷锟斤拷锟竭憋拷锟斤拷锟斤拷锟斤拷(CDRH):
锟斤拷锟斤拷锟斤拷锟斤拷确锟斤拷锟斤拷锟斤拷锟叫碉拷医锟斤拷锟斤拷械锟侥帮拷全锟斤拷锟斤拷效锟斤拷锟斤拷为锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟揭碉拷锟斤拷锟斤拷锟窖拷羌锟斤拷锟角碉拷锟剿癸拷锟斤拷锟斤拷锟侥わ拷瘸锟斤拷锟斤拷锟斤拷锟斤拷指锟斤拷锟斤拷锟斤拷偷锟揭斤拷锟斤拷锟叫碉拷锟斤拷锟叫╋拷锟狡凤拷锟斤拷锟酵拷说锟斤拷锟斤拷锟较⑾拷锟截的ｏ拷锟斤拷锟斤拷锟酵憋拷锟斤拷锟杰凤拷围锟节碉拷锟桔猴拷锟斤拷锟饺★拷锟斤拷锟斤拷一些锟斤拷微锟斤拷炉锟斤拷锟斤拷锟接伙拷锟斤拷锟狡讹拷锟界话锟斤拷锟杰诧拷锟斤拷锟斤拷锟斤拷锟竭的诧拷品锟斤拷锟斤拷也确锟斤拷锟斤拷一些锟斤拷应锟侥帮拷全锟斤拷准锟斤拷
锟斤拷锟斤拷4锟斤拷锟斤拷锟斤拷锟斤拷品锟斤拷锟斤拷锟斤拷锟叫撅拷(CBER):
锟斤拷锟斤拷锟矫硷拷锟斤拷锟叫╋拷芄锟皆わ拷锟斤拷锟斤拷锟斤拷萍锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟狡凤拷锟斤拷锟剿比伙拷学锟桔猴拷锟斤拷药锟斤拷锟斤拷痈锟斤拷樱锟斤拷锟斤拷锟斤拷锟斤拷锟窖猴拷锟窖拷锟斤拷锟斤拷锟斤拷锟饺的帮拷全锟皆猴拷锟斤拷效锟皆斤拷锟叫匡拷学锟叫撅拷锟斤拷
锟斤拷锟斤拷5锟斤拷锟斤拷锟斤拷药品(CVM):
锟斤拷锟斤拷医锟斤拷锟斤拷证
锟斤拷锟斤拷FDA锟斤拷医锟斤拷锟斤拷械锟侥癸拷锟斤拷通锟斤拷锟斤拷械锟斤拷锟斤拷浣★拷锟?CDRH)锟斤拷锟叫的ｏ拷锟洁督医锟斤拷锟斤拷械锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷装锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟截凤拷锟斤拷锟铰斤拷锟叫撅拷营锟筋动锟斤拷
锟斤拷锟斤拷医锟斤拷锟斤拷械锟斤拷围锟杰广，小锟斤拷医锟斤拷锟斤拷锟阶ｏ拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷FDA锟洁督之锟铰ｏ拷锟斤拷锟斤拷医锟斤拷锟斤拷途锟酵讹拷锟斤拷锟斤拷锟斤拷艿锟斤拷撕锟斤拷锟紽DA锟斤拷医锟斤拷锟斤拷械锟斤拷为锟今、Ⅱ、拷锟洁，越锟斤拷锟斤拷锟洁督越锟斤拷.
锟斤拷锟斤拷锟斤拷锟斤拷锟狡凤拷锟斤拷谐锟斤拷喜锟斤拷锟斤拷锟斤拷诘锟斤拷锟接憋拷锟斤拷锟斤拷锟紽DA要锟襟厂家斤拷锟斤拷锟较革拷锟斤拷锟斤拷锟绞碉拷椋拷锟斤拷锟斤拷锟斤拷锟斤拷欧锟斤拷锟揭窖э拷锟酵筹拷锟窖еわ拷锟剿碉拷锟斤拷锟狡凤拷锟斤拷锟叫э拷院桶锟饺拷浴锟?/p>
锟斤拷锟斤拷医锟斤拷锟斤拷械锟斤拷FDA锟斤拷证锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷FDA注锟结、锟斤拷品锟斤拷FDA锟角记★拷锟斤拷品锟斤拷锟叫登硷拷(510锟斤拷锟角硷拷)锟斤拷锟斤拷品锟斤拷锟斤拷锟斤拷锟斤拷锟阶?PMA锟斤拷锟? 医锟狡憋拷锟斤拷锟斤拷械锟侥憋拷签锟诫技锟斤拷锟斤拷锟届、通锟截★拷锟角记★拷锟斤拷锟斤拷前锟斤拷锟芥，锟斤拷锟结交锟斤拷锟铰诧拷锟较ｏ拷(1)锟斤拷装锟斤拷锟斤拷锟侥诧拷锟斤拷品锟斤拷荩锟?2)锟斤拷械锟斤拷锟斤拷图锟斤拷锟斤拷锟斤拷锟斤拷说锟斤拷锟斤拷(3)锟斤拷械锟斤拷锟斤拷锟杰硷拷锟斤拷锟斤拷原锟斤拷;(4)锟斤拷械锟侥帮拷全锟斤拷锟斤拷证锟斤拷锟斤拷锟斤拷锟斤拷希锟?5)锟斤拷锟届工锟秸硷拷椋?6)锟劫达拷锟斤拷锟斤拷锟杰结，(7)锟斤拷品说锟斤拷锟斤拷. 锟斤拷锟斤拷锟叫碉拷锟斤拷蟹锟斤拷锟斤拷锟斤拷芑锟斤拷头欧锟斤拷锟斤拷锟斤拷锟斤拷剩锟斤拷锟斤拷锟斤拷锟较革拷锟斤拷锟斤拷锟?/p>
锟斤拷锟斤拷药品锟斤拷证
锟斤拷锟斤拷FDA锟斤拷医药锟斤拷品锟斤拷一锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷证锟斤拷锟斤拷锟皆憋拷确锟斤拷锟斤拷药锟侥帮拷全锟斤拷锟斤拷效.锟矫筹拷锟斤拷锟斤拷锟铰ｏ拷
锟斤拷锟斤拷1. 锟叫撅拷锟斤拷锟斤拷药锟斤拷锟斤拷 (IND):
锟斤拷锟斤拷锟斤拷锟斤拷药锟斤拷司锟斤拷FDA锟捷斤拷IND,FDA锟斤拷锟斤拷药锟侥硷拷饪硷拷锟?锟斤拷时锟斤拷药锟斤拷锟斤拷锟斤拷实锟斤拷锟斤拷未锟斤拷始锟斤拷FDA锟斤拷要锟斤拷锟斤拷锟斤拷獍踩拷锟斤拷锟斤拷攵拷锟绞碉拷锟斤拷锟斤拷荩锟斤拷跃锟斤拷锟斤拷锟揭╋拷欠锟斤拷愎伙拷锟饺拷锟斤拷锟斤拷锟斤拷锟绞碉拷锟阶讹拷.
锟斤拷锟斤拷2.锟斤拷锟斤拷实锟介：
锟斤拷锟斤拷锟斤拷锟斤拷实锟介共锟斤拷4锟斤拷锟阶讹拷. 一锟斤拷锟斤拷要锟斤拷锟斤拷药锟斤拷陌锟饺拷裕锟斤拷锟揭拷锟斤拷锟斤拷茫锟斤拷锟叫伙拷锟斤拷锟斤拷锟斤拷龋锟斤拷锟斤拷锟斤拷锟揭伙拷锟叫★拷诮锟?0.
锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷要锟斤拷锟斤拷药锟斤拷锟斤拷锟叫э拷裕锟斤拷跃锟斤拷锟揭┢凤拷欠锟斤拷锟斤拷锟叫э拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟? 同时锟斤拷药品锟侥帮拷全锟斤拷锟诫毒锟斤拷锟斤拷锟斤拷也锟斤拷锟斤拷锟叫观诧拷亩锟斤拷锟? 锟斤拷锟斤拷实锟斤拷锟斤拷锟斤拷锟斤拷锟揭伙拷锟叫★拷锟?00.
锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟绞碉拷锟斤拷锟斤拷斯锟斤拷瑁拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷裕锟绞碉拷锟斤拷锟斤拷锟斤拷锟斤拷. 锟斤拷锟节斤拷锟斤拷锟斤拷锟斤拷同锟斤拷锟斤拷锟斤拷危锟斤拷锟酵拷锟斤拷锟饺猴拷锟斤拷氩煌拷锟斤拷锟揭╋拷锟斤拷锟斤拷锟饺拷锟斤拷锟叫撅拷药锟侥帮拷全锟斤拷锟斤拷锟斤拷效锟斤拷. 锟斤拷锟斤拷实锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷诩锟斤拷俚锟斤拷锟角э拷锟斤拷锟?
锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷要锟斤拷锟斤拷药锟斤拷准锟斤拷锟斤拷校锟斤拷锟揭拷锟斤拷锟揭╋拷锟侥筹拷锟节帮拷全锟皆ｏ拷锟铰碉拷锟斤拷群锟斤拷.
锟斤拷锟斤拷3.锟斤拷药锟斤拷锟斤拷 (NDA):
锟斤拷锟斤拷锟斤拷锟斤拷药锟斤拷司锟斤拷锟斤拷锟斤拷锟斤拷锟绞碉拷椋拷锟街わ拷锟斤拷锟揭╋拷陌锟饺拷锟叫э拷院锟斤拷锟绞斤拷锟紽DA锟结交NDA锟斤拷锟斤拷. FDA锟斤拷锟饺拷锟斤拷亩锟斤拷锟斤拷锟斤拷锟斤拷锟绞碉拷锟斤拷锟斤拷荩锟斤拷约锟揭╋拷锟侥达拷锟斤拷锟斤拷锟斤拷锟斤拷荩锟揭╋拷锟斤拷锟斤拷锟斤拷锟紾MP锟斤拷锟捷ｏ拷锟斤拷锟斤拷锟斤拷莶锟饺拷虿缓锟斤拷锟斤拷锟紽DA锟斤拷芫锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟紽DA锟斤拷锟斤拷10锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟较ｏ拷锟斤拷锟斤拷同锟斤拷锟杰撅拷锟斤拷锟?
锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷锟斤拷摘锟皆★拷MTG FDA锟斤拷证锟斤拷锟斤拷锟斤拷锟斤拷植帷?/p>
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