Kev tsim kho tshiab ua rau muaj kev vam meej.Thaum nws los txog rau kev tsim kho tshiab hauv kev tsim cov tshuaj tshiab thiab cov khoom siv tshuaj lom neeg, FDA's Center for Drug Evaluation and Research (CDER) txhawb kev lag luam tshuaj ntawm txhua kauj ruam ntawm cov txheej txheem.Nrog rau nws txoj kev nkag siab txog kev tshawb fawb siv los tsim cov khoom tshiab, kev sim thiab cov txheej txheem tsim khoom, thiab cov kab mob thiab cov xwm txheej uas cov khoom tshiab tau tsim los kho, CDER muab cov lus qhia txog kev tshawb fawb thiab kev tswj hwm xav tau los coj cov kev kho tshiab rau kev ua lag luam.
Kev muaj cov tshuaj tshiab thiab cov khoom siv roj ntsha feem ntau txhais tau tias kev kho mob tshiab rau cov neeg mob thiab kev nce qib hauv kev kho mob rau pej xeem Asmeskas.Vim li no, CDER txhawb nqa kev tsim kho tshiab thiab ua lub luag haujlwm tseem ceeb hauv kev pab txhawb kev txhim kho tshuaj tshiab.
Txhua xyoo, CDER pom zoo ntau yam tshuaj tshiab thiab cov khoom siv roj ntsha:
1. Qee yam ntawm cov khoom no yog cov khoom tshiab tshiab uas tsis tau siv rau hauv kev kho mob.Hauv qab no yog cov npe ntawm cov koom haum tshiab molecular thiab cov khoom siv kho mob tshiab tau pom zoo los ntawm CDER hauv 2021. Cov npe no tsis muaj cov tshuaj tiv thaiv, cov khoom ua xua, cov ntshav thiab cov ntshav, cov ntshav plasma derivatives, cellular thiab noob kho cov khoom, lossis lwm yam khoom tau pom zoo hauv 2021 los ntawm lub Center for Biologics Evaluation and Research.
2. Lwm tus yog tib yam li, lossis cuam tshuam nrog, cov khoom tau pom zoo yav dhau los, thiab lawv yuav sib tw nrog cov khoom lag luam hauv khw.Saib Drugs@FDA kom paub txog txhua yam ntawm CDER cov tshuaj pom zoo thiab cov khoom siv roj ntsha.
Qee cov tshuaj raug cais raws li cov chaw tshiab molecular ("NMEs") rau lub hom phiaj ntawm FDA tshuaj xyuas.Ntau yam ntawm cov khoom no muaj cov active moieties uas tsis tau pom zoo los ntawm FDA yav tas los, xws li ib yam tshuaj muaj los yog raws li ib feem ntawm cov khoom ua ke;cov khoom no nquag muab cov kev kho tshiab tseem ceeb rau cov neeg mob.Qee cov tshuaj muaj tus cwj pwm zoo li NMEs rau kev tswj hwm lub hom phiaj, tab sis txawm li cas los xij muaj cov moieties uas muaj feem cuam tshuam nrog kev ua haujlwm moieties hauv cov khoom uas yav dhau los tau pom zoo los ntawm FDA.Piv txwv li, CDER faib cov khoom siv roj ntsha xa mus rau hauv daim ntawv thov raws li Tshooj 351 (a) ntawm Public Health Service Act raws li NMEs rau lub hom phiaj ntawm FDA tshuaj xyuas, txawm hais tias lub koom haum yav dhau los tau pom zoo muaj feem cuam tshuam rau cov khoom sib txawv.FDA qhov kev faib tawm ntawm cov tshuaj raws li "NME" rau kev tshuaj xyuas yog txawv ntawm FDA qhov kev txiav txim siab ntawm seb cov khoom siv tshuaj puas yog "cov tshuaj tshiab" lossis "NCE" nyob rau hauv lub ntsiab lus ntawm Tsoom Fwv Teb Chaws Khoom Noj, Tshuaj, thiab Tshuaj pleev ib ce.