PDUFA Performance Dashboard Performance Dashboard app
INCWADI YOMYALELO
I PDUFA Performance Dashboards zicwangciswe ngokweendidi ezintathu: 1) Izicelo zeziyobisi ezimiselweyo kunye nezongezelelo; 2) Izaziso zeNkqubo kunye neeMpendulo; kunye 3) noLawulo lweeNtlanganiso. Udidi ngalunye lubandakanya iDashboard yeNtsebenzo yangoku kunye neyeMbali enemenyu yokukhangela kunye nee-icons phezulu kwideshbhodi nganye. Imenyu kunye nee-ayikhoni ziquka ulwazi:
1. PDUFA IiDashbhodi zeNtsebenzo yangoku zodidi ngalunye ezibonisa eyona minyaka mibini yakutshanje yokusebenza kwinjongo nganye.
2. I-PDUFA Historical Performance Dashboards kwicandelo ngalinye ebonisa umsebenzi wembali kwinjongo nganye
3. Iphepha leKhaya le-FDA-TRACK lamachiza
4. Iphepha leKhaya le-FDA-TRACK Biologics
5. PDUFA Dashboard User Guide
6. Iphepha leKhaya le-FDA-TRACK
7. Unxulumano olufanelekileyo malunga nePDUFA
8. Imvelaphi ngokubanzi malunga nePDUFA
I-FDA-TRACK: Ukusebenza kwePDUFA
Ukusebenza kwangoku
Iphepha leNtsebenzo yangoku yeDashboard yeNtsebenzo yePDUFA ibonisa iminyaka emibini yamva nje yokusebenza kwinjongo nganye esekiweyo kunye nowona nyaka wakutsha nje wokusebenza kwiinjongo ezisanda kwenziwa ezimiselwe phantsi kwePDUFA VII. Xa kuxelwa ngaphezu konyaka omnye wedatha, iinkcukacha zonyaka wokuqala zezokugqibela, kwaye iinkcukacha zonyaka wesibini zisandulela kunye nezinye izenzo ezisalindileyo.
Iphepha leNdlela yokuSebenza yaNgoku libonisa itshati yebha eqokelelweyo kunyaka ngamnye wokwenziwa komsebenzi:
- Umbala wecandelo ngalinye lebar umele ubume:
-IBlue imele izenzo ezigqityiweyo "Ngexesha," okanye ngaphakathi kwenjongo;
– IGrey imele izenzo “Pending,” okanye ngaphakathi kwenjongo nalapho kungekho manyathelo athathiweyo;
- I-Orange imele izenzo "Ixesha elidlulileyo," apho inyathelo lithathwe emva komhla wokujolisa, okanye akukho manyathelo athathiweyo kwaye idlulile umhla wokujolisa. - Ibha nganye iphawulwe ngenani leentshukumo kuloo meko, ngaphandle kwakwiimeko apho umthamo wezenzo ezineso simo sincinci kakhulu. Kwezinye iimeko, ileyibhile ye-review Isimo asizukubonakala kwigrafu ngenxa yesithuba. Olu lulungiselelo oluzenzekelayo oluzenzekelayo kwi-software yokubonwayo. Ukuba uhambisa ikhesa phezu kwecandelo legrafu apho ileyibhile ingekhoyo, iinkcukacha zeleyibhile ziya kuvela kwiSixhobo seSixhobo.
- "Injongo Yokusebenza" iboniswa njengomgca othe nkqo oqinileyo kwigrafu:
-Ukuba ibha eluhlaza okwesibhakabhaka ifikelela kumgca wenjongo yokusebenza ukusuka ngasekhohlo, imeko yenjongo ithi "Injongo Met", okanye "Iza kuhlangabezana neNjongo."
-Ukuba ibha engwevu iwela umgca wokukora wentsebenzo kwaye iPesenti ngexesha lidibana okanye ligqithise injongo yokusebenza, imeko yenjongo ithi "Intlanganiso yangoku, ilindile." Ukuba ibar engwevu iwela umgca wokukora wentsebenzo kwaye iPesenti yeXesha ingaphantsi kwenjongo, imeko yenjongo ithi "Okwangoku ayikadibani, ilindile." Ukuba ibha ye-orenji ifikelela kumgca wokukora wokusebenza ukusuka ekunene, imeko yenjongo ithi "Injongo Ayihlangatyezwanga" okanye "Ayiyi Kuhlangabezana neNjongo."
Kwi-example ngezantsi, 182 ungeniso kwaba filed ngo-FY 2020. Kwezo zingeniso, i-91% (166) ifezekise injongo yentsebenzo, ngelixa i-9% (16) ayizange. Kuba ibha ye-orenji ayifikeleli kumgca wokukora wokusebenza ukusuka ekhohlo, imeko yaloo njongo yi "Goal Met." Ngo-FY 2021, ama-255 angenisiweyo aye filed I-64% (163) ibisexesheni, i-30% (76) ibisalindile, kwaye i-6% (16) ibishiywe lixesha. Kuba ibar engwevu ifikelela kumgca wokukora, imeko yaloo njongo ithi "Intlanganiso yangoku, ilindile."
Ukubona "Ingcebiso yesixhobo” ebonisa ulwazi olongezelelweyo, hambisa ikhesa phezu kwemo nganye kwibar, njengoko kubonisiwe kwi-example ngezantsi.
ISixhobo seSixhobo sibonelela ngamaqhekeza amaninzi olwazi. Ezi ziquka:
- Unyaka-mali: Unyaka-mali wokufumana ungeniso ngokuxhomekeke kwinjongo.
- Injongo: Injongo yentsebenzo, uhlobo lwesenzo, kunye nohlaziyoview ixesha lenjongo.
- Iintshukumo:
- Kwidatha yokugqibela, inani lezenzo eziphuma kwitotali ezazisexesheni.
- Kwidatha yokuqala, inani lezenzo ezigqityiweyo, kungakhathaliseki ukuba zazifike ngexesha okanye ziphelile, kuzo zonke izenzo ezinokubakho. - Ipesenti ngexesha: Ipesenti yezenzo eziye zafikelela usukelo.
- Owona msebenzi uphezulu onokuthi uphunyezwe ukuba yonke into ethi "Pending" ekungenisweni kwenjongo ithathwa ngokwenjongo.
- I-Goal Met Status: Amanqaku athi “Goal Met,” “Will Meet Goal,” “Okwangoku Meeting, Pending,” “Okwangoku Ayihlangani, Ilindile,” “Ayiyi Kuhlangabezana Nosukelo,” okanye “Injongo Ayifezekanga.”
- Inani lokungeniswa: Kwimeko echaziweyo, inani lokungeniswa libandakanyiwe kweso simo.
- Ipesenti yeTotali: Kwimo echaziweyo, ipesentitage inxenye yezingeniso ngokunxulumene netotali (100%).
- Amanqaku ongezelelweyo: Naluphi na ulwazi olongezelelweyo olufanelekileyo malunga nendlela injongo yokusebenza ethile ilinganiswa ngayo.
Ukusebenza ngokwembali
Iphepha leNtsebenzo yezeMbali yeDashboard yokuSebenza kwePDUFA ibonisa iminyaka emithandathu edlulileyo yedatha kwinjongo nganye yokusebenza. Iminyaka emihlanu edlulileyo yedatha yeyokugqibela kwaye unyaka odlulileyo wedatha, onokubandakanya iinjongo ezisanda kuphunyezwa, uyisiqalo kunye nezenzo ezisalindileyo. Isihluzo seNjongo yokuSebenza ngaphezulu kwetshati ivumela ukhetho lwenjongo njengoko kubonwa kwi-example ngezantsi.
I-FDA-TRACK: PDUFA Historical Performance - Izicelo zeDrugs zeDrugs kunye nezongezelelo
Idatha yomthwalo wokusebenza imele inani lokungeniswa ngokuxhomekeke kwiinjongo ezithile ngexesha lokubuyisela ichizaview inkqubo. Umgca “womndilili” kwigrafu umele umndilili wenani lokungeniswayo kwisithuba seminyaka emihlanu yedatha yokusebenza yokugqibela, ngaphandle kwedatha yokuqala.
Iiseti zedatha kunye nemibhalo esemazantsi
Idatha kwideshbhodi nganye inokukhutshelwa ngokukhetha iqhosha ledatha ngezantsi kwedeshbhodi nganye, njengoko kubonisiwe ngezantsi kuMsebenzi waNgoku weZicelo zeDyza elimiselweyo kunye neDashboard yezoNgezelelo.
Khuphela i-Prescription Drug Applications and Supplements Dataset
Imibhalo esemazantsi inikwe ngezantsi kwedeshbhodi nganye ebonisa ulwazi olufanelekileyo, umzekeloample, ukuqaphela ukuba ngaba kukho utshintsho kwiinjongo zokusebenza, okanye ukuba idatha yeyokuqala.
Imibhalo esemazantsi:
* Ukusebenza ngokwakaloku nje kweyokuqala ngenxa yezimvo ezisalindelweyo.
*”* Owona msebenzi we-FY wamva nje kunye nedatha yokusebenza ibandakanya izicelo ezichongiweyo njengezingatyunjwanga, nto leyo ethetha ukuba ,~phakathi kweentsuku ezingama-60 zokufayilisha kwaye azikabikho ukutyunjwa kwakhona, umgangatho okanye umba ophambili owenziweyo.
Iinkcukacha:
- Iindidi: Izicelo zeziyobisi ezimiselweyo kunye nezongezelelo, iZaziso zeNkqubo kunye neeMpendulo, uLawulo lweNtlanganiso
- IiDashbhodi zokuSebenza: Zangoku kunye nezeMbali zodidi ngalunye
- Iimpawu: Imenyu yokukhangela, ii-icons zokufikelela ngokulula kulwazi
FAQ
Umbuzo: Ndingayikhuphela njani idatha kwiideshibhodi?
A: Uyakwazi ukukhuphela idatha ngokukhetha iqhosha ledatha ngezantsi kwedeshbhodi nganye.
Umbuzo: Umele ntoni umgca ophakathi kwigrafu?
IMPENDULO: Umgca ophakathi umele umndilili wenani lokungeniswayo kwisithuba seminyaka emihlanu yedatha yokusebenza yokugqibela, ngaphandle kwedatha yokuqala.
Amaxwebhu / Izibonelelo
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PDUFA Performance Dashboard Performance Dashboard app [pdf] Incwadi Yomyalelo Usetyenziso lweDashboard yokuSebenza, iNtsebenzo, usetyenziso lweDashboard, usetyenziso |
