Rwendo rwaJUUL's PMTA Rwendo: Yekutanga PMTA Yakaunzwa naJuul seTechnical Solution yePublic-Health Matambudziko

PMTA yeJUUL

Musi waChikunguru 19, 2023, Juul Labs, iyo inopayona e-fodya kambani, yakazivisa kuendesa kwayo yekutanga Premarket Fodya Chigadzirwa Chikumbiro (PMTA) yechizvarwa chinotevera chikuva chevapor kuUS Food and Drug Administration (FDA). Muchiito chekuvandudza chinosanganisa kufunga nezvehutano uye tekinoroji yepamberi, kambani iyi inoshandisa mudziyo mutsva pamwe nemapodhi matsva anefodya ane 18 mg/mL nicotine concentration. Iyi puratifomu inounza zvakare matekinoroji anofambiswa nedatha akatarisana nekudzora kupinda kwevashandisi vasati vabva zera.

 

Rwendo rwaJUUL rwePMTA

Kirk Phelps, Chief Product Officer, akasimbisa kuti hunyanzvi hwakaiswa muDNA yekambani. "Chikuva chedu chechizvarwa chinotevera imhinduro yetekinoroji kumatambudziko maviri ehutano hweveruzhinji - kushandura vanhu vakuru vanoputa kubva kumidzanga inobvira uye kudzikisira kuwanikwa kwevasati vasvika kune zvigadzirwa zvemhute. Uku ndiko chete kutanga kwehurongwa hwedu hwekunatsa nekuvandudza tekinoroji nyowani yemusika weUS uye nekumwe. Chinangwa chedu ndechekubvisa fodya inobvira uye kumisa kushandiswa kwevadiki," Phelps akadaro.

 

Yakatangwa muUK muna 2021 seJUUL2 System, iyi yekucheka-kumucheto mhute chikuva inopa yakagadziridzwa mhute ruzivo kune vakuru vanoputa. Mamiriro ayo akasiyana anosanganisira Pod ID yechokwadi kugadzirisa dambudziko rezvigadzirwa zvemanyepo, uye tekinoroji yekuongorora zera kuderedza kushandiswa kwevadiki.

 

Zvimiro zveiyi puratifomu yakakwidziridzwa, iyo yakaziviswa nevakuru vanoputa ruzivo, zvinosanganisira:

 

  • Chiitiko chemhute chakavimbika chinokwikwidzana nefodya inobvira.
  • Chishandiso chinogonesa Bluetooth chakaiswa bhatiri hombe, rinogara kwenguva refu uye "smart light system" inozivisa vashandisi nezvehupenyu hwebhatiri uye. e-mvura Level.
  • Ichangobva kugadzirwa, inodzivirira-inodzivirira mapodhi anowedzera aerosol kutumira.
  • Chinhu chitsva chekudziya chinosimudzira kuita kwechigadzirwa uye tembiricha-yekudzora kurongeka.
  • Iyo yakasarudzika Pod ID chip inodzivirira kushandiswa zvisiri pamutemo uye mapodhi anoenderana neanotevera-chizvarwa mudziyo.
  • Chishandiso chenharembozha uye chewebhu chinogonesa tekinoroji yekuongorora zera, kusanganisira kukiya-kiya mudziyo, uye inopa ruzivo rwechigadzirwa chenguva chaiyo uye ruzivo rwemashandisirwo kune vatengi vane zera, ine indasitiri inotungamira kudzivirira kuvanzika kwedata.

 

Tsvagiridzo yekutanga yehunhu paJUUL2 System muUK inoratidza kutorwa kwakanyanya uye kuchinja pakati pevasvuta vakuru, nevanopfuura 32% yevashandisi vakasandura zvizere kubva kufodya inobvira mwedzi mitanhatu vatenga chigadzirwa. Kunyangwe kubudirira kweiyo JUUL System iri kutengeswa, iyo yakabatsira vanopfuura mamirioni maviri veku US vanoputa vakura kuita shanduko, Juul Labs aneshungu yekuunza tekinoroji yavo yehunyanzvi kune vanofungidzirwa mamirioni makumi maviri nemasere vanoputa fodya munyika vachiri kushandisa fodya inopisa. chikonzero chikuru chekufa kunodzivirika.

 

“Chizvarwa chedu chinotevera vapor platform PMTA yakavakirwa pahunyanzvi tekinoroji inosimudzira hutano hweveruzhinji zvinangwa. Sainzi inomanikidza kuseri kwayo inoratidza bhenefiti yehutano hweveruzhinji, chinodiwa kuti uwane mvumo yekushambadzira, "akadaro Joe Murillo, Chief Regulatory Officer. "Tinotarisira kusangana neFDA panguva yese yekuongorora isu tichiyedza kuunza mukana uyu wakakosha wekudzikisa kukuvadza."

Rwendo rwaJUUL rwePMTA

Uku kutumirwa kwePMTA kunoumba chikamu chakakosha cheJuul Lab yakapamhama zano rekupa inoshanda, sainzi-inotsigirwa dzimwe nzira dzevakuru vanoputa kuti vashanduke kure nefodya inobvira. Iyo kambani iri kuenderera mberi nekuedza kwayo kumisa kushandiswa kwevadiki nekuunza nekuvandudza tekinoroji mhinduro.

Rwendo rwaJUUL rwePMTA, PMTAJuul Labs parizvino ari kukwidza danho reFDA rekuramba mvumo yeJUUL System. Iyo kambani inoramba ichiti ichawana mvumo yekushambadzira kana sarudzo yabva pane humbowo hwesainzi, isina kupindira mune zvematongerwo enyika.

 

Basa rekambani rekuvandudza hutano hweveruzhinji rinoonekwa mukuzvipira kwavo kune zvigadzirwa zvitsva uye kugadzirwa kwehumbowo hwesainzi. Vanovimbisa kuenderera mberi nekutungamira chikamu ichi nemhinduro itsva, vachiedza kubvisa fodya inobvira kuitira kusimudzira hutano hweveruzhinji.

 

Pazasi pane pfupiso yekutumirwa kwaJuul Labs 'PMTA kusvika parizvino(rwendo rwaJUUL's PMTA):

 

  • PMTAs yeIzvino-Yakatengeswa JUUL System - Yakatumirwa muna Chikunguru 2020; parizvino, chikumbiro chekutonga chakamirira uye zvigadzirwa zveJUUL zvinoramba zviripo kune vanhu vakuru vanoputa.
  • PMTAs yeNew Fodya Flavour sechikamu cheIri-Yakatengeswa JUUL System - Yakatumirwa muna Zvita 2022; parizvino iri kuongororwa.
  • PMTAs yeInotevera-Generation Vapor Platform - Yakatumirwa muna Chikunguru 2023; parizvino yakamirira kuongororwa kugamuchirwa.

 

Link: https://www.juullabs.com/next-generation-platform-pmta/

Irely william
Author: Irely william

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