Video: FDA black box ceeb toom npe yog dab tsi?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
Boxed ceeb toom . Hauv Tebchaws Meskas, a thawv ceeb toom (qee zaum " black box ceeb toom ", colloquially) yog hom ceeb toom uas tshwm nyob rau hauv pob ntxig rau qee yam tshuaj noj, yog li hu ua vim US Food and Drug Administration qhia tias nws yog formatted nrog ' lub thawv 'los yog ciam teb ib ncig ntawm cov ntawv nyeem.
Ib yam li ntawd, FDA ceeb toom lub thawv dub yog dab tsi?
A black box ceeb toom tshwm nyob rau ntawm daim ntawv lo ntawm cov tshuaj noj kom ceeb toom rau cov neeg siv khoom thiab cov kws kho mob txog kev txhawj xeeb txog kev nyab xeeb, xws li kev phom sij loj lossis kev phom sij rau lub neej. A black box ceeb toom yog cov tshuaj loj tshaj plaws ceeb toom xav tau los ntawm US Food and Drug Administration ( FDA ).
Ib tug kuj yuav nug, cov chav kawm tshuaj twg muaj lub thawv dub ceeb toom? A black box ceeb toom los yog thawv ceeb toom yog U. S. Food and Tshuaj Cov thawj coj loj tshaj plaws ceeb toom rau tshuaj thiab cov khoom siv kho mob. A tshuaj los yog ntaus ntawv nrog a black box ceeb toom muaj kev phiv uas yuav ua rau mob hnyav lossis tuag taus.
Hais txog qhov no, pes tsawg cov tshuaj muaj cov lus ceeb toom ntawm lub thawv dub?
Nrog ntau tshaj 600 tshuaj nqa boxed ceeb toom thiab ntau dua 40% ntawm cov neeg mob nyob rau hauv qhov chaw kho mob amulatory tau txais tsawg kawg yog ib qho tshuaj nrog a black box ceeb toom , Nws yog ib qho tseem ceeb rau cov kws kho mob yuav tsum paub txog cov tshuaj uas nquag sau tseg tshuaj uas muaj cov kev phiv loj heev ceeb toom.
Puas yog Seroquel muaj lub thawv dub ceeb toom?
FDA tau muaj tso ob dub - lub thawv ceeb toom ntawm Seroquel : Cov neeg muaj dementia muaj muaj kev pheej hmoo ntxiv rau kev tuag thaum nyob rau Seroquel . Yog tias koj lossis ib tus neeg hauv tsev neeg tuaj yeem muaj dementia, tham nrog kws kho mob txog qhov no ua ntej noj Seroquel . Thib ob, Seroquel tej zaum yuav ua rau koj muaj feem yuav tua tus kheej.
Pom zoo:
Daim ntawv ceeb toom txog txoj cai kom tau txais daim ntawv ntsuam xyuas yog dab tsi?
Zoo, txoj cai tau txais daim ntawv theej ntawm daim ntawv ntsuam xyuas yog ib qho kev nthuav qhia qhia cov neeg thov qiv nyiaj ntawm lawv txoj cai kom tau txais daim ntawv theej ntawm daim ntawv txheeb xyuas uas cuam tshuam nrog cov neeg thov qiv nyiaj los ntawm cov tsev nyob
Daim ntawv ceeb toom qhia tawm ntawm tus muag khoom yog dab tsi?
Qhov kev ceeb toom no yog nthuav tawm ntawm tus neeg muag khoom paub txog qhov xwm txheej ntawm kev muaj vaj huam sib luag raws li hnub uas tau kos npe los ntawm tus muag khoom thiab tsis yog tus xa rau ib qho kev tshuaj xyuas lossis kev lees paub ntawm tus neeg yuav khoom xav tau. Nws tsis yog kev lav phib xaub ntawm txhua yam los ntawm tus muag khoom, tus neeg muag khoom, lossis lwm tus neeg sawv cev
Leej twg yuav tsum kos npe rau ib tus neeg muag khoom daim ntawv ceeb toom nthuav tawm?
A: Cov Lus Qhia Tshaj Tawm Txog Tus Muag Khoom yog ib txoj hauv kev rau cov neeg yuav khoom hauv tsev kom muaj cov ntaub ntawv ntau li ntau tau txog qhov xwm txheej ntawm cov khoom ua ntej yuav khoom. Cov kev tshaj tawm no xav kom tus neeg muag khoom sau cov ntaub ntawv paub txog qhov tsis xws luag lossis ua haujlwm tsis zoo nrog rau kev saib xyuas keeb kwm kom zoo tshaj plaws ntawm lawv txoj kev paub
Lub npe thiab lub npe ntawm tus neeg saib xyuas FDA yog dab tsi?
Cov neeg ua haujlwm. Stephen Hahn, MD Tus Thawj Saib Xyuas Khoom Noj thiab Tshuaj Hauv Tebchaws Meskas yog tus thawj coj ntawm Food and Drug Administration (FDA), lub koom haum ntawm Tebchaws Meskas Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tib Neeg. Tus thawj coj raug xaiv los ntawm Thawj Tswj Hwm ntawm Tebchaws Meskas nrog cov lus qhia thiab kev pom zoo los ntawm Senate
Daim ntawv ceeb toom them nyiaj puas tuaj yeem yog daim ntawv ceeb toom them tsawg dua?
Raws li peb tau hais los saum no, luv luv cov lus teb tsis yog. Raws li Txoj Cai Kev Tsim Kho 1996 (raws li tau teev tseg), ntu 111(1) tau tso cai rau tus neeg them nyiaj sib sau ua ke daim ntawv ceeb toom them nyiaj thiab daim ntawv ceeb toom txiav rau hauv ib daim ntawv ceeb toom (tsuas yog nws teev tag nrho cov ntsiab lus tsim nyog rau ob daim ntawv ceeb toom)