Dab tsi yog Phau Ntawv Txiv Kab Ntxwv siv rau hauv chaw muag tshuaj?

2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17

Kev tshaj tawm Pom zoo cov khoom siv tshuaj nrog kev sib npaug sib npaug Kev ntsuam xyuas (feem ntau hu ua Orange Book) txheeb xyuas cov khoom siv tshuaj pom zoo raws li kev nyab xeeb thiab kev ua tau zoo los ntawm Food and Drug Administration (FDA) raws li Tsoom Fwv Teb Chaws Khoom Noj, Tshuaj, thiab Tshuaj pleev ib ce (Txoj Cai) thiab lwm yam patent thiab

Tib neeg kuj nug, Dab tsi yog cov tshuaj Orange Book?

Cov Txiv kab ntxwv phau ntawv yog ib qho tseem ceeb tshaj tawm luam tawm los ntawm FDA uas ua hauj lwm raws li tus qauv kub siv rau generic tshuaj hloov. Daim ntawv tshaj tawm tag nrho yog pom zoo Tshuaj Cov khoom lag luam nrog Kev Ntsuam Xyuas Kev Ntsuas Sib npaug, tab sis nws feem ntau hu ua Txiv kab ntxwv phau ntawv.

Qhov thib ob, dab tsi yog qhov tsim nyog rau cov khoom lag luam kom tau raws li Orange Book kho qhov sib npaug? FDA cais raws li kev kho mob sib npaug cov tshuaj cov khoom tias ntsib cov nram qab no general yam : (1) lawv raug pom zoo tias muaj kev nyab xeeb thiab siv tau; (2) lawv yog cov tshuaj sib npaug nyob rau hauv hais tias lawv (a) muaj zoo tib yam npaum li cas ntawm cov zoo tib yam active tshuaj muaj nyob rau hauv lub zoo tib yam npaum li cas daim ntawv thiab txoj kev ntawm

Xav txog qhov no, muaj pes tsawg cov tshuaj nyob hauv Phau Ntawv Txiv Kab ntxwv?

Tsis tas li ntawd, cov Txiv kab ntxwv phau ntawv muaj kev ntsuam xyuas qhov sib npaug (2 tus lej ntsuas tus lej) rau kev pom zoo ntau yam tshuaj tshuaj cov khoom (generic tshuaj ).

Vim li cas phau ntawv txiv kab ntxwv hu ua Orange Book?

Txawm hais tias nws yog feem ntau hu ua Orange Book , nws lub npe raug pom zoo yog Cov Khoom Siv Tshuaj Pom Zoo nrog Kev Ntsuas Kev Ntsuas Zoo. Cov tshuaj uas nws txoj kev nyab xeeb lossis kev pom zoo tau raug tshem tawm raug tshem tawm los ntawm Txiv kab ntxwv phau ntawv.