Uhlelo lokusebenza le-PDUFA Yokusebenza Kwedeshibhodi Yokusebenza
INCWADI YOMYALELO
I Amadeshibhodi Wokusebenza we-PDUFA zihlelwe zaba izigaba ezintathu: 1) Izicelo Zezidakamizwa Ezinikezwa Kadokotela Nezithasiselo; 2) Izaziso Zenqubo Nezimpendulo; kanye 3) Nokuphathwa Komhlangano. Isigaba ngasinye sihlanganisa Ideshibhodi Yokusebenza Kwamanje Neyomlando enemenyu yokuzulazula nezithonjana phezulu kudeshibhodi ngayinye. Imenyu nezithonjana zihlanganisa ulwazi loku:
1. Amadeshibhodi Okusebenza Kwamanje e-PDUFA wesigaba ngasinye abonisa iminyaka emibili yakamuva yokusebenza kwegoli ngalinye
2. Amadeshibhodi Okusebenza Komlando we-PDUFA wesigaba ngasinye abonisa ukusebenza komlando kwegoli ngalinye
3. Ikhasi Lasekhaya le-FDA-TRACK Izidakamizwa
4. Ikhasi Lasekhaya Le-FDA-TRACK Biologics
5. I-PDUFA Dashboard User Guide
6. Ikhasi Lasekhaya le-FDA-TRACK
7. Izixhumanisi Ezifanelekile mayelana ne-PDUFA
8. Isizinda esijwayelekile mayelana ne-PDUFA
I-FDA-TRACK: Ukusebenza kwe-PDUFA
Ukusebenza Kwamanje
Ikhasi Lokusebenza Kwamanje Ledeshibhodi Yokusebenza ye-PDUFA libonisa iminyaka emibili yakamuva yokusebenza ngomgomo ngamunye omisiwe kanye nonyaka wakamuva kakhulu wokusebenza wemigomo esanda kufakwa esungulwe ngaphansi kwe-PDUFA VII. Uma kubikwa idatha engaphezu konyaka owodwa, idatha yonyaka wokuqala iba ngujuqu, futhi idatha yonyaka wesibili ingeyokuqala kanti ezinye izenzo zisalindile.
Ikhasi Lokusebenza Kwamanje libonisa ishadi lebha estakiwe yonyaka ngamunye wokusebenza:
- Umbala wesegimenti ngayinye yebha umele isimo:
- Okuluhlaza okwesibhakabhaka kumelela izenzo eziqedwe “Ngesikhathi,” noma ngaphakathi komgomo;
– Okumpunga kumelela izenzo “Ezilindile,” noma ngaphakathi komgomo nalapho kungekho sinyathelo esithathiwe;
– Iwolintshi imelela izenzo “Ezidlulelwe yisikhathi,” lapho isenzo sithathwe ngemva kwedethi yomgomo, noma kungekho sinyathelo esithathiwe futhi seludlule idethi yomgomo. - Ibha ngayinye ibhalwe inombolo yezenzo kuleso simo, ngaphandle kwasezimeni lapho umthamo wezenzo ezinaleso simo lincane kakhulu. Kwezinye izimo, ilebula ye-review isimo ngeke siboniswe kugrafu ngenxa yesikhala. Lokhu ukulungiselelwa okuzenzakalelayo okuzenzakalelayo kusofthiwe yokubuka. Uma uhambisa ikhesa phezu kwesigaba segrafu lapho ilebula ingekho khona, imininingwane yelebula izovela kokuthi Ithulithiphu.
- "Umgomo Wokusebenza" uboniswa njengomugqa oqondile oqinile kugrafu:
– Uma ibha eluhlaza okwesibhakabhaka ifinyelela umugqa wegoli lokusebenza ukusuka kwesokunxele, isimo segoli sithi “Goal Met”, noma “Will Meet Goal.”
- Uma ibha empunga yeqa umugqa wegoli lokusebenza futhi Iphesenti Lesikhathi lihlangabezana noma lidlula umgomo wokusebenza, isimo somgomo sithi "Okwamanje Umhlangano, Ulindile." Uma ibha empunga yeqa umugqa wegoli lokusebenza futhi Iphesenti Lesikhathi lingaphansi komgomo, isimo somgomo sithi "Okwamanje Awuhlangani, Alindile." Uma ibha ewolintshi ifinyelela umugqa wegoli lokusebenza ukusuka kwesokudla, isimo segoli sithi “Goal Not Met” noma “Will Not Meet Goal.”
Ku-example ngezansi, izethulo eziyi-182 zazikhona filed ngo-FY 2020. Kulezo ziphakamiso, ama-91% (166) afinyelele umgomo wokusebenza, kuyilapho u-9% (16) engazange. Njengoba ibha ewolintshi ingafinyeleli emugqeni wegoli lokusebenza ukusuka kwesokunxele, isimo salowo mgomo sithi “Goal Met.” Ngo-FY 2021, izethulo ezingama-255 zazikhona filed; U-64% (163) ubesesikhathini, u-30% (76) usalindile, kanti u-6% (16) udlulelwe yisikhathi. Njengoba ibha empunga ifinyelela umugqa wegoli, isimo salowo mgomo sithi "Okwamanje Umhlangano, Ulindile."
Ukuze ubone "Ithulithiphu” ebonisa ulwazi olwengeziwe, hambisa ikhesa phezu kwesimo ngasinye kubha, njengoba kuboniswe ku-example ngezansi.
I-Tooltip inikeza izingcezu ezimbalwa zolwazi oluwusizo. Lokhu kubandakanya:
- Unyaka Wezimali: Unyaka Wezimali wokwamukela ukuhanjiswa kuncike enjongweni.
- Umgomo: Umgomo wokusebenza, uhlobo lwesenzo, nokuphindaview isikhathi segoli.
- Izenzo:
- Ngedatha yokugcina, inani lezenzo enani eliphelele ebelinesikhathi.
- Ngedatha yokuqala, inani lezenzo eziqediwe, kungakhathaliseki ukuthi bezifike ngesikhathi noma zedlulelwe yisikhathi, kuzo zonke izenzo ezingenzeka. - Amaphesenti Ngesikhathi: Iphesenti lezenzo ezihlangabezane nomgomo.
- Ukusebenza Okuphakeme Kakhulu: Ukusebenza okuphezulu kakhulu okungafezwa uma konke "Okulindiwe" ngaphakathi kokuthunyelwa komgomo kwenziwa ngaphakathi komgomo.
- I-Goal Met Status: Izimo zithi “Goal Met,” “Will Meet Goal,” “Okwamanje Meeting, Pending,” “Okwamanje Ayihlangani, Ilindile,” “Will Not Meet Goal,” noma “Goal Not Met.”
- Inombolo Yokuthunyelwa: Ngesimo esicacisiwe, inombolo yokuthunyelwa efakwe kuleso simo.
- Iphesenti Lengqikithi: Ngesimo esithile, iphesentitage ingxenye yeziphakamiso maqondana nengqikithi (100%).
- Amanothi Engeziwe: Noma yiluphi ulwazi olungeziwe olubalulekile mayelana nokuthi umgomo othile wokusebenza ulinganiswa kanjani.
Ukusebenza Komlando
Ikhasi Lokusebenza Komlando Ledeshibhodi Yokusebenza ye-PDUFA libonisa idatha yeminyaka eyisithupha edlule yomgomo ngamunye wokusebenza. Iminyaka emihlanu edlule yedatha ingeyokugcina futhi unyaka odlule wedatha, ongafaka phakathi imigomo esanda kuqaliswa, ungowokuqala ngezenzo ezisalindile. Isihlungi Somgomo Wokusebenza ngenhla kweshadi sivumela ukukhethwa kwegoli njengoba kubonakala ku-example ngezansi.
I-FDA-TRACK: Ukusebenza Komlando kwe-PDUFA - Izicelo Zezidakamizwa Ezibhalwe Kadokotela Nezithasiselo
Idatha yomthwalo wokusebenza imele inombolo yokuthunyelwa ngaphansi kwemigomo ethile ngesikhathi somuthi kabushaview inqubo. Ulayini “omaphakathi” ngegrafu umelela inani elimaphakathi lokuhanjiswa phakathi nenkathi yeminyaka emihlanu yedatha yokusebenza kokugcina, ngaphandle kwedatha yokuqala.
Amasethi edatha kanye nemibhalo yaphansi
Idatha kudeshibhodi ngayinye ingalandwa ngokukhetha inkinobho yedathasethi ngezansi kwedeshibhodi ngayinye, njengoba kuboniswe ngezansi Ukusebenza Kwamanje Kwedeshibhodi Yezicelo Zezidakamizwa Ezibhalwe Kadokotela kanye Nezithasiselo.
Landa Izicelo Zomuthi Kadokotela Nedathasethi Yezithasiselo
Imibhalo yaphansi inikezwe ngezansi kwedeshibhodi ngayinye ebonisa ulwazi olufanele, isiboneloample, siqaphela ukuthi kube khona izinguquko ezinhlosweni zokusebenza, noma ukuthi idatha ingeyokuqala.
Imibhalo yaphansi:
* Ukusebenza okwamanje kungokokuqala ngenxa yeziphakamiso ezilindile.
*”* Inani lakamuva kakhulu le-FY yomthwalo womsebenzi kanye nedatha yokusebenza ihlanganisa izinhlelo zokusebenza ezikhonjwa njengezingakhethiwe, okusho ukuthi ,~phakathi nedethi yokugcwalisa yezinsuku ezingu-60 futhi azikakabi nakho ukuqokwa kabusha, okujwayelekile noma okubalulekile, okwenziwe.
Imininingwane:
- Izigaba: Izicelo Zezidakamizwa Ezibhalwe Kadokotela Nezithasiselo, Izaziso Zenqubo Nezimpendulo, Ukuphathwa Komhlangano
- Amadeshibhodi Okusebenza: Okwamanje kanye Nomlando wesigaba ngasinye
- Izici: Imenyu yokuzulazula, izithonjana zokufinyelela kalula olwazini
FAQ
Umbuzo: Ngingayilanda kanjani idatha kumadeshibhodi?
A: Ungalanda idatha ngokukhetha inkinobho yesethi yedatha ngezansi kwedeshibhodi ngayinye.
Q: Umelelani umugqa omaphakathi kugrafu?
IMP: Ulayini omaphakathi umele inombolo emaphakathi yokuthunyelwa phakathi nenkathi yeminyaka emihlanu yedatha yokusebenza yokugcina, ngaphandle kwedatha yokuqala.
Amadokhumenti / Izinsiza
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Uhlelo lokusebenza le-PDUFA Yokusebenza Kwedeshibhodi Yokusebenza [pdf] Incwadi Yeziqondiso Uhlelo lokusebenza lwedeshibhodi yokusebenza, Ukusebenza, uhlelo lokusebenza lwedeshibhodi, uhlelo lokusebenza |
