PDUFA Performance Dashboard Performance Dashboard app

CHIKONZERO CHEMIRAIRO

Navigation uye Ruzivo Rwakakodzera

The PDUFA Performance Dashboards zvakarongwa muzvikamu zvitatu: 1) Prescription Drug Applications uye Supplements; 2) Procedural Notifications uye Mhinduro; uye 3) Meeting Management. Chikamu chega chega chinosanganisira Yazvino uye Nhoroondo Yekuita Dashboard ine menyu yekufambisa uye zvidhori pamusoro peimwe dashboard. Menyu uye zvidhori zvinosanganisira ruzivo ku:

1. PDUFA Current Performance Dashboards echikamu chimwe nechimwe anoratidza makore maviri achangopfuura ekuita kwechinangwa chimwe nechimwe.
2. PDUFA Historical Performance Dashboards echikamu chega chega anoratidza kuita kwenhoroondo yechinangwa chimwe nechimwe
3. FDA-TRACK Drugs Home Page
4. FDA-TRACK Biologics Home Peji
5. PDUFA Dashboard User Guide
6. FDA-TRACK Peji Yemba
7. Relevant Links pamusoro pePDUFA
8. General background nezvePDUFA

FDA-TRACK: PDUFA Performance

Current Performance

Iyo Yazvino Performance peji yePDUFA Performance Dashboard inoratidza makore maviri achangopfuura ekuita kwechinangwa chimwe nechimwe chakagadzwa uye gore razvino rekuita kwezvinangwa zvichangobva kuitwa zvakasimbiswa pasi pePDUFA VII. Kana inopfuura gore rimwe redata richitaurwa, data regore rekutanga ndiro rekupedzisira, uye data regore rechipiri nderokutanga nezvimwe zviito zvichiri kumirira.

Iyo Yazvino Performance peji inoratidza yakarongedzwa bar chart yegore rega rega rekuita:

• Rudzi rwechikamu chega chega chebhari rinomiririra chimiro:
  - Bhuruu inomiririra zviito zvakapedzwa "Nenguva," kana mukati mechinangwa;
  - Grey inomiririra zviito "Pending," kana mukati mechinangwa uye pasina chiito chakaitwa;
  - Orange inomiririra zviito "Zvakapera," apo chiito chakatorwa mushure mezuva rechinangwa, kana kuti hapana chiito chakaitwa uye yapfuura zuva rechinangwa.
• Bhawa rega rega rakanyorwa nenhamba yezviito muchimiro ichocho, kunze kwezviitiko apo huwandu hwezviito zvine chimiro ichocho hudiki zvakanyanya. Mune zvimwe zviitiko, iyo label ye review chimiro hachizoonekwe mugirafu nekuda kwenzvimbo. Iyi ndiyo otomatiki yekumisikidza kugadzika mune yekuona software. Kana ukasimudza cursor pamusoro pechikamu chegirafu pasisina label, zvinyorwa zvemazita zvinoonekwa paTooltip.
• Iyo "Performance Goal" inoratidzwa semutsara wakasimba wakatwasuka pagirafu:
  -Kana bhara rebhuruu rasvika pamutsetse wechinangwa kubva kuruboshwe, chinzvimbo chechinangwa ndeche "Goal Met", kana "Ichasangana Nechinangwa."
  -Kana grey bar ikayambuka mutsara wechinangwa chekuita uye Percent On Time inosangana kana kudarika chinangwa chekuita, chinzvimbo chechinangwa ndeche "Parizvino Musangano, Wakamirira." Kana iyo grey bar ikayambuka mutsara wechinangwa chekuita uye Percent PaNguva iri pazasi pechinangwa, chinzvimbo chechinangwa ndeche "Parizvino Haisi Kusangana, Yakamirira." Kana bhara reorenji rasvika pamutsetse wechinangwa chekuita kubva kurudyi, chinzvimbo chechinangwa ndeche "Chinangwa Chisina Kusangana" kana "Hachizosangana Nechinangwa."

Mune example pazasi, 182 zvakatumirwa zvaive filed muFY 2020. Pane izvo zvakatumirwa, 91% (166) yakazadzisa chinangwa chekuita, nepo 9% (16) haina. Sezvo bhara reorenji risingasviki pamutsetse wechinangwa kubva kuruboshwe, chimiro chechinangwa ichocho "Goal Met." Muna FY 2021, 255 zvakatumirwa zvaive filed; 64% (163) vaiva nenguva, 30% (76) vakanga vachiri kumirira, uye 6% (16) vakanga vanonoka. Sezvo grey bar ichisvika pamutsetse wechinangwa, chimiro chechinangwa ichocho "Parizvino Musangano, Wakamirira."

Kuona "Tooltip” iyo inoratidza rumwe ruzivo, simudza chitubu pane imwe neimwe mamiriro pabha, sezvakaratidzwa mune example pazasi.

 

Iyo Tooltip inopa akati wandei anobatsira eruzivo. Izvi zvinosanganisira:

• Gore Rezvemari: Gore reMari rekugamuchira iyo yekutumira zvichienderana nechinangwa.
• Chinangwa: Chinangwa chekuita, rudzi rwechiito, uye review nguva yechinangwa.
• Zviito
  -Kune data yekupedzisira, nhamba yezviito kunze kweiyo yakazara yaive nenguva.
  -Kune data rekutanga, nhamba yezviito zvinopedzwa, zvisinei nekuti vaive nenguva kana nguva, kubva pane zvese zvingaite.
• Percent panguva: Chikamu chezviito zvakazadzisa chinangwa.
• Kuita Kwepamusoro Kunogoneka: Kuita kwepamusoro-soro kunogona kuwanikwa kana zvese "Pending" mukati mezvinangwa zvinotumirwa zvikaitwa mukati mechinangwa.
• Goal Met Status: Mamiriro acho ndeaya “Goal Met,” “Will Meet Goal,” “Parizvino Meeting, Pending,” “Parizvino Haisati Yasangana, Yakamirira,” “Haichazadzisa Chinangwa,” kana kuti “Chinangwa Chisina Kuzadzikiswa.”
• Nhamba Yekutumira: Kune yakatarwa chimiro, nhamba yekutumira inosanganisirwa mune iyo mamiriro.
• Percent yeTotal: Pachimiro chakatarwa, chikamutage chikamu chekutumira maererano nehuwandu (100%).
• Mamwe Manotsi: Chero ruzivo rwekuwedzera rwakakodzera nezve kuti chinangwa chekuita chinoyerwa sei.

Historical Performance

Iyo Historical Performance peji yePDUFA Performance Dashboard inoratidza makore matanhatu apfuura edhata yechinangwa chega chega chekuita. Makore mashanu apfuura edata ndeekupedzisira uye gore rapfuura re data, iro rinogona kusanganisira zvichangobva kuitwa zvinangwa, nderekutanga nezviito zvichiri kumirira. Iyo Performance Goal Sefa iri pamusoro pechati inobvumira kusarudzwa kwechinangwa sekuonekwa mune example pazasi.

FDA-TRACK: PDUFA Historical Performance - Prescription Drug Applications uye Supplements

Data rebasa rinomiririra huwandu hwekutumira pasi pezvinangwa zvakananga panguva yemishonga review process. Iyo "avhareji" mutsara kuburikidza negirafu inomiririra avhareji yenhamba yekutumira mukati memakore mashanu ekupedzisira data data, kusasanganisa yekutanga data.

Datasets uye Manyoro

Iyo data iri mudeshibhodhi yega yega inogona kudhaunirodwa nekusarudza bhatani re dataset pazasi pedashibhodhi rega rega, sezvaratidzwa pazasi peMaitiro Azvino eKunyorerwa Kushandiswa Kwezvinodhaka uye Dashboard Yekuwedzera.

Dhawunirodha Prescription Drug Applications uye Supplements Dataset

Zvinyorwa zvepazasi zvinopihwa pazasi dashboard yega yega inoratidza ruzivo rwakakodzera, rweexample, tichiona kana paine shanduko muzvinangwa zvekuita, kana kuti data ndeyekutanga.

Mashoko emuzasi:
* Kuita parizvino kuri kwekutanga nekuda kwekumirira kutumira.
*”* Iyo ichangoburwa yeFY basa uye data rekuita rinosanganisira zvikumbiro zvinoonekwa sezvisina kudomwa, zvinoreva kuti zvichiri ,~mukati memazuva makumi matanhatu ekunyora uye hazvisati zvave nere, re, chirevo, chiyero kana chakakosha, chakaitwa.

Zvinodiwa:

• Categories: Prescription Drug Applications and Supplements, Procedural Notifications and Responses, Meeting Management
• Performance Dashboards: Yazvino uye Nhoroondo kune yega yega chikamu
• Zvimiro: Navigation menyu, zvidhori zvekuwana nyore ruzivo

---

FAQ

Mubvunzo: Ndingatora sei data kubva kumabhodhi?

A: Unogona kudhawunirodha data nekusarudza bhatani re dataset pazasi pedhibhodhi yega yega.

Mubvunzo: Mutsetse wepakati mugirafu unomirirei?

A: Mutsara wepakati unomiririra huwandu hwehuwandu hwekutumira mukati memakore mashanu ekupedzisira data data, kusasanganisa yekutanga data.

Zvinyorwa / Zvishandiso

PDUFA Performance Dashboard Performance Dashboard app [pdf] Bhuku reMirayiridzo Performance Dashboard app, Kuita, Dashboard app, app

References

• User Manual