Video: CFR hauv FDA yog dab tsi?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
Txoj Cai ntawm Tsoom Fwv Teb Chaws Txoj Cai ( CFR ) yog ib codification ntawm cov kev cai dav dav thiab mus tas li luam tawm nyob rau hauv Tsoom Fwv Teb Chaws Register los ntawm lub Executive departments thiab cov koom haum ntawm tsoom fwv.. Title 21 ntawm lub CFR yog tseg rau cov cai ntawm Food and Drug Administration.
Ib yam li ntawd, tshooj twg ntawm 21 CFR muaj cov cai los ntawm FDA?
Title 21 CFR Nws Part 11 yog ib feem ntawm Title 21 ntawm Code of Federal Kev cai uas tsim tsa Tsoomfwv Meskas Cov Khoom Noj thiab Tshuaj ( FDA ) cov kev cai ntawm cov ntaub ntawv hluav taws xob thiab kos npe hluav taws xob (ERES).
Ib yam li ntawd, muaj pes tsawg feem muaj nyob hauv 21 CFR? Nws muaj peb tshooj, txhua qhov tshwj xeeb hauv cov lej rau cov koom haum no. 21 CFR Nws feem ntau paub txog 21 cfr ib ntu 11 hluav taws xob kos npe. Tab sis nws muaj qhov sib txawv cov muaj txawv cov txheej txheem yuav tsum tau ua raws li kev lag luam.
Yog li ntawd, CFR yog dab tsi hauv kev sim tshuaj?
CFR - Code of Federal Regulations - Txoj Cai Federal Regulations ( CFR ) yog cov kev cai luam tawm los ntawm tsoomfwv cov koomhaum, suav nrog FDA. Cov npe tshwj xeeb hauv lub CFR siv rau Zoo kho mob Xyaum hauv kho mob kev tshawb fawb, suav nrog: 21 CFR Tshooj 812 (Kev Tshawb Fawb Cov Cuab Yeej Exemption)
FDA txhais li cas ntawm cov cuab yeej kho mob?
A khoom siv kho mob yog txhais Tsis pub dhau lub Food Drug & Cosmetic Act li "ib qho cuab yeej, cuab yeej, siv, tshuab, contrivance, implant, in vitro reagent, los yog lwm yam zoo sib xws los yog cov tshooj lus, nrog rau ib feem, los yog accessory uas yog: lees paub nyob rau hauv lub official National Formulary, los yog Tebchaws Meskas
Pom zoo:
FDA CFR 21 yog dab tsi?
Title 21 yog ib feem ntawm Txoj Cai Tswjfwm Txoj Cai Tswjfwm zaub mov thiab tshuaj hauv Tebchaws Meskas rau Food and Drug Administration (FDA), Lub Chaw Saib Xyuas Tshuaj Yeeb Tshuaj (DEA), thiab Office of National Drug Control Policy (ONDCP)
Dab tsi txaus ntshai zoo kawg li nws yog qhov peb yuav tsum tau khawb trenches thiab sim cov roj npog qhov ncauj qhov ntswg ntawm no vim muaj kev sib cav nyob hauv lub tebchaws nyob deb ntawm cov neeg uas peb tsis paub dab tsi?
Qhov txaus ntshai npaum li cas, zoo heev, zoo kawg yog tias peb yuav tsum tau khawb trenches thiab sim roj-qhov ncauj qhov ntswg ntawm no vim muaj kev sib cav nyob rau hauv ib lub teb chaws nyob deb ntawm cov neeg uas peb tsis paub dab tsi. Nws zoo nkaus li tseem tsis yooj yim dua tias kev sib cav uas twb tau hais tseg hauv txoj cai yuav tsum yog kev ua tsov rog
Qhov txawv ntawm CFR thiab CNF yog dab tsi?
C&F, CNF lossis CFR txhais tau tias Tus Nqi & Freight. Ntawm no, tus nqi muag khoom ntawm kev muag khoom suav nrog tus nqi thiab freight ntawm cov khoom. Kuv yuav piav qhia txog CFR (tseem hu ua CNF thiab C&F) cov ntsiab lus ntawm kev xa khoom nrog piv txwv yooj yim. Kev tuav pov hwm ntawm cov khoom tau ntsib los ntawm tus neeg yuav khoom hauv caseof C&F kev lag luam
Dab tsi yog peb txoj kab hauv qab peb lub hauv paus koom ua ke rau hauv Lub Ntiaj Teb Kev Tshaj Tawm Kev Tshaj Tawm Txoj Haujlwm?
Dab tsi yog peb txoj kab hauv qab kab hauv qab tau muab tso rau hauv Lub Ntiaj Teb Kev Tshaj Tawm Kev Tshaj Tawm Txoj Haujlwm? kev coj ncaj ncees thiab kev cai lij choj. cov thawj coj lossis cov neeg ua haujlwm ncaj ncees. Kev soj ntsuam kev sib raug zoo thiab kev soj ntsuam kev coj ncaj ncees ua tau zoo ib yam, yog li cov koom haum tuaj yeem siv lawv sib pauv
CFR sawv cev rau dab tsi hauv kev sim tshuaj?
CRO tuaj yeem pab saib xyuas, tshuaj xyuas, kev tswj xyuas qhov project thiab lwm yam, pab kom ua raws li kev soj ntsuam thiab ua raws li kev sim tshuaj. CFR - Code of Federal Regulations - Txoj Cai Federal Regulations (CFR) yog ib txheej ntawm cov kev cai luam tawm los ntawm tsoomfwv cov koomhaum, suav nrog FDA