PDUFA Performance Dashboard Performance Dashboard app

OLELO HOOLAHA

Hoʻokele a me ka ʻike pili

ʻO ka Nā Papa Hana Hana PDUFA ua hoʻonohonoho ʻia i ʻekolu mau ʻāpana: 1) Nā noi a me nā mea hoʻohui i ka lāʻau lapaʻau; 2) Nā Hoʻolaha Kūlana a me nā pane; a me 3) Hooponopono Halawai. Loaʻa i kēlā me kēia ʻāpana kahi papa hana o kēia manawa a me ka mōʻaukala me kahi papa kuhikuhi a me nā kiʻi ma ka piko o kēlā me kēia dashboard. Aia i loko o ka papa kuhikuhi a me nā ikona ka ʻike no:

1. PDUFA Nā Papa Hana Hana o kēia manawa no kēlā me kēia māhele e hōʻike ana i ʻelua makahiki hope loa o ka hana no kēlā me kēia pahu hopu
2. PDUFA Historical Performance Dashboards no kēlā me kēia māhele e hōʻike ana i ka hana mōʻaukala no kēlā me kēia pahu hopu
3. ʻAoʻao Home Lapaʻau FDA-TRACK
4. ʻAoʻao Home FDA-TRACK Biologics
5. PDUFA Dashboard Mea Hoʻohana
6. ʻAoʻao Home FDA-TRACK
7. Nā loulou pili e pili ana iā PDUFA
8. Ka moʻolelo maʻamau e pili ana iā PDUFA

FDA-TRACK: PDUFA Performance

Hana i kēia manawa

Hōʻike ka ʻaoʻao hana o kēia manawa o ka PDUFA Performance Dashboard i ʻelua mau makahiki hope loa o ka hana no kēlā me kēia pahuhopu i hoʻokumu ʻia a me ka makahiki hope loa o ka hana no nā pahuhopu hou i hoʻokō ʻia ma lalo o PDUFA VII. Ke hōʻike ʻia ka ʻikepili i ʻoi aku ma mua o hoʻokahi makahiki, ʻo ka ʻikepili o ka makahiki mua ka hope, a ʻo ka ʻikepili o ka makahiki ʻelua he hoʻomaka me kekahi mau hana e kali nei.

Hōʻike ka ʻaoʻao hana o kēia manawa i kahi pakuhi pahu i hoʻopaʻa ʻia no kēlā me kēia makahiki o ka hana:

• Hōʻike ke kala o kēlā me kēia māhele o ka pā i ke kūlana:
  - Hōʻike ka polū i nā hana i hoʻopau ʻia "Ma ka manawa," a i ʻole i loko o ka pahuhopu;
  - Hōʻike ʻo Gray i nā hana "Pending," a i ʻole i loko o ka pahu hopu a kahi i hana ʻole ʻia;
  – Hōʻike ka ʻalani i nā hana "Overdue," kahi i hana ʻia ma hope o ka lā pahuhopu, a i ʻole ʻaʻohe hana i hana ʻia a hala ka lā pahuhopu.
• Hoʻopaʻa ʻia kēlā me kēia pā me ka helu o nā hana i kēlā kūlana, koe naʻe nā hihia inā he liʻiliʻi loa ka nui o nā hana me kēlā kūlana. I kekahi mau manawa, ka lepili no ka review ʻaʻole e hōʻike ʻia ke kūlana ma ka pakuhi ma muli o ke ākea. He hoʻonohonoho paʻamau ʻakomi kēia i ka polokalamu ʻike. Inā ʻoe e kau i ka piko ma luna o ka ʻāpana o ka pakuhi kahi i nalowale ai ka lepili, e ʻike ʻia nā kikoʻī lepili ma ka Tooltip.
• Hōʻike ʻia ka "Pahuhopu Hana" ma ke ʻano he laina kūpaʻa paʻa ma ka pakuhi:
  – Inā hōʻea ka pahu polū i ka laina pahu hopu hana mai ka hema, ʻo ke kūlana pahuhopu ʻo "Goal Met", a i ʻole "Will Meet Goal."
  – Inā hele ka pahu hina i ka laina pahu hopu hoʻokō a hui a ʻoi paha ka Pakeneka On Time i ka pahuhopu hoʻokō, ʻo ke kūlana pahuhopu ʻo "Hālawai i kēia manawa, ke kali nei." Inā hele ka pahu hina i ka laina pahu hopu hana a ʻo ka Pakeneka On Time ma lalo o ka pahu hopu, ʻo ke kūlana pahu hopu ʻo "ʻAʻole Halawaʻi, Ke kali nei." Inā hōʻea ka pahu ʻalani i ka laina pahu hopu hana mai ka ʻākau, ʻo ke kūlana pahu hopu ʻo "ʻAʻole i ʻike ʻia ka Pahuhopu" a i ʻole "E Hoʻokō ʻole i ka Pahuhopu."

I ka exampma lalo iho nei, he 182 mau palapala filed i ka FY 2020. No kēlā mau hoʻouna, 91% (166) i hoʻokō i ka pahuhopu hoʻokō, aʻo 9% (16) ʻaʻole. No ka mea ʻaʻole hiki i ka pahu ʻalani i ka laina pahuhopu hana mai ka hema, ʻo ke kūlana o kēlā pahuhopu ʻo "Goal Met." I ka FY 2021, 255 mau hoʻouna filed; 64% (163) i ka manawa, 30% (76) e kali ana, a he 6% (16) ua hala. Ma muli o ka hōʻea ʻana o ka pahu hina i ka laina pahu hopu, ʻo ke kūlana o kēlā pahuhopu ʻo "Hālawai i kēia manawa, ke kali nei."

E ʻike i kahi "Mea kōkua” e hōʻike ana i nā ʻike hou aʻe, e kau i ka cursor ma luna o kēlā me kēia kūlana ma kahi pā, e like me ka hōʻike ʻana ma ka example lalo.

 

Hāʻawi ka Tooltip i nā ʻāpana ʻike pono. Aia kēia mau mea:

• Makahiki Waiwai: ʻO ka Makahiki Waiwai o ka loaʻa ʻana mai o ka waiho ʻana ma lalo o ka pahuhopu.
• Pahuhopu: Ka pahuhopu hana, ʻano hana, a me ka hana houview manawa o ka pahu hopu.
• Nā hana:
  - No ka ʻikepili hope loa, ka helu o nā hana mai ka huina o ka manawa.
  - No ka ʻikepili mua, ka helu o nā hana i hoʻopau ʻia, me ka nānā ʻole i ka manawa a i ʻole i hala, ma waho o nā hana āpau.
• Ka pakeneka o ka manawa: Ka pakeneka o nā hana i hoʻokō i ka pahuhopu.
• ʻO ka hana kiʻekiʻe loa: ʻO ka hana kiʻekiʻe loa e hiki ke hoʻokō inā hoʻokō ʻia nā "Pending" a pau i loko o nā hoʻouna pahu hopu.
• Kūlana Pahuhopu: ʻO nā statuses ʻo "Goal Met," "Will Meet Goal," "Currently Meeting, Kali ʻia," "I kēia manawa ʻAʻole Hui, Ke kali nei," "ʻAʻole e Hoʻokō i ka Pahuhopu," a i ʻole "Pahuhopu ʻAʻole Met."
• Ka helu o nā waiho ʻana: No kahi kūlana i ʻōlelo ʻia, ka helu o nā hoʻouna i hoʻokomo ʻia ma ia kūlana.
• Pākēneka o ka huina: No ke kūlana i kuhikuhi ʻia, ka pākēnekatagʻāpana o ka waiho ʻana e pili ana i ka huina (100%).
• Nā memo hou aʻe: ʻO nā ʻike hou aʻe e pili ana i ke ana ʻana o kahi pahuhopu hana kikoʻī.

Hana Moolelo

Hōʻike ka ʻaoʻao Historical Performance o ka PDUFA Performance Dashboard i nā makahiki ʻeono i hala o ka ʻikepili no kēlā me kēia pahuhopu hana. ʻO nā makahiki ʻelima i hala aku nei o ka ʻikepili he hope loa ia a ʻo ka makahiki i hala o ka ʻikepili, hiki ke komo i nā pahuhopu hou i hoʻokō ʻia, ʻo ia ka mua me nā hana e kali nei. Hiki i ka kānana Performance Goal ma luna o ka pakuhi ke koho i kahi pahu hopu e like me ka ʻike ma ka example lalo.

FDA-TRACK: PDUFA Historical Performance – Laau Laau Laau Laau Laau a me na Mea Koko

Hōʻike ka ʻikepili hana i ka helu o nā hoʻouna ma lalo o nā pahuhopu kikoʻī i ka wā o ka lāʻau houview kaʻina hana. ʻO ka laina "awelika" ma o ka pakuhi e hōʻike ana i ka helu awelika o nā hoʻouna ma luna o ka ʻelima makahiki o ka ʻikepili hana hope, me ka ʻole o ka ʻikepili mua.

Nā ʻikepili a me nā memo wāwae

Hiki ke hoʻoiho ʻia ka ʻikepili i kēlā me kēia dashboard ma ke koho ʻana i ka pihi ʻikepili ma lalo o kēlā me kēia dashboard, e like me ka mea i hōʻike ʻia ma lalo nei no ka hana o kēia manawa no nā noi lāʻau lapaʻau a me nā papa hoʻohui.

Hoʻoiho i nā noi lāʻau lapaʻau a me nā mea hoʻohui ʻikepili

Hāʻawi ʻia nā footnote ma lalo o kēlā me kēia dashboard e hōʻike ana i ka ʻike pili, no ka example, e ʻike ana inā he mau hoʻololi i nā pahuhopu hana, a i ʻole he ʻikepili mua.

Nā memo wāwae:
* Hoʻomaka mua ka hana ma muli o nā waiho ʻana.
*”* ʻO ka ʻikepili hana FY hou loa a me ka ʻikepili hana e pili ana i nā noi i ʻike ʻia ʻaʻole i koho ʻia, ʻo ia hoʻi, aia nō lākou, ~ i loko o ka lā 60-lā waiho ʻana a ʻaʻole i loaʻa kahi koho hou, maʻamau a i ʻole ka mea nui.

Nā kikoʻī:

• Māhele: Nā noi lāʻau lapaʻau a me nā mea hoʻohui, nā hoʻolaha a me nā pane o ke kaʻina hana, ka hoʻokele hālāwai.
• Nā Papa Hana Hana: ʻO kēia a me ka mōʻaukala no kēlā me kēia māhele
• Nā hiʻohiʻona: Navigation menu, ikona no ka maʻalahi o ka ʻike

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FAQ

Nīnau: Pehea e hiki ai iaʻu ke hoʻoiho i ka ʻikepili mai nā dashboards?

A: Hiki iā ʻoe ke hoʻoiho i ka ʻikepili ma ke koho ʻana i ka pihi ʻikepili ma lalo o kēlā me kēia dashboard.

Nīnau: He aha ka laina awelika o ka pakuhi?

A: Hōʻike ka laina awelika i ka helu awelika o nā hoʻouna ʻana i loko o ka ʻelima makahiki o ka ʻikepili hana hope, me ka ʻole o ka ʻikepili mua.

Palapala / Punawai

PDUFA Performance Dashboard Performance Dashboard app [pdf] Palapala Aʻo Papahana Papahana Papahana, Papahana Papahana, app

Nā kuhikuhi

• Palapala Hoʻohana