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Nhasi, iyo US Food and Drug Administration iri kupa pfupiso-pfupi yenhau kubva kune yakatenderedza agency:

  • Nhasi, iyo FDA yakayambira vatengi nezve njodzi yekupinzwa netsaona, kunyanya nevana, yezvinodyiwa zvine THC.Kumedzwa netsaona kwezvinhu izvi zvinodyika zvinogona kukonzera zviitiko zvakakomba.
  • Nhasi, iyo FDArakabudiswanhungamiro yekupedzisira ine musoro unoti "Kuderedza Njodzi Dzinochengeteka Kwekudya Mukugadzirwa kweMbeu Yekumera: Kutungamira kuIndasitiri.”Nhungamiro iyi inotaridza kushushikana kukuru kweFDA pamusoro pekubuda kwechirwere chechikafu chine chekuita nekudyiwa kwembeu mbishi uye yakabikwa zvishoma uye inopa mafemu matanho anokurudzirwa ekudzivirira hupombwe mukati mekugadzirwa kwembeu kuti imere.
  • NeChina, iyo FDAakabvumira kushambadzirayezvigadzirwa zvitsva zvitanhatu zvefodya kuburikidza nePremarket Tobacco Product Application (PMTA) nzira.Iyo FDA yakaburitsakushambadzira kwakapihwa maodha (MGO)kuRJ Reynolds Vapor Kambani yeVuse Vibe yayoe-fodya mudziyouye inoperekedza fodya-flavored yakavharwae-liquid pod, pamwe neiyo Vuse Ciro e-fodya yefodya uye inoperekedza fodya-yakanaka yakavharwa.e-mvurapod.Iyo FDA yakapawo kushambadzira kwekuramba mirairo kuRJ Reynolds Vapor Kambani yemamwe akawanda Vuse Vibe uye Vuse Ciro.e-fodya zvigadzirwa.Pamusoro pezvo, zvigadzirwa zve menthol-flavored zvakaunzwa nekambani zvichiri pasi pekuongororwa kweFDA.
  • Nemusi weChina, iyo FDA yakabvumidza Radicava ORS (edaravone) kumiswa nemuromo kurapwa kweamyotrophic lateral sclerosis (ALS).Radicava ORS ishanduro inopihwa nemuromo yeRadicava, yaiveyakatanga kubvumidzwa muna 2017 senge intravenous (IV) infusionkurapa ALS, inowanzonzi chirwere cheLou Gehrig.Radicava ORS inozvitungamira uye inogona kutorwa kumba.Mushure mekutsanya kwehusiku hwose, Radicava ORS inofanira kutorwa mangwanani nemuromo kana kuburikidza nechubhu yekudyisa.Mishonga yemuromo ine imwecheteyo dosing regimen seRadicava-yekutanga kurapwa kutenderera kwemazuva ese kudhowa kwemazuva gumi nemana, inoteverwa ne14-zuva-isina-isina-zvinodhaka nguva uye inotevera kurapa kutenderera kunosanganisira zuva nezuva dosing ye10 kubva ku14-mazuva-nguva, inoteverwa. nemazuva gumi nemana pasina zvinodhaka.Migumisiro yakajairika yeRadicava ndeyekupwanya (contusions), matambudziko ekufamba (gait disturbances), uye misoro.Kuneta zvakare kunogona kuitika kubva kuRadicava ORS.Radicava uye Radicava ORS inogona kuva nemigumisiro yakakomba inobatanidza nemigumisiro yeallergic inosanganisira mikoko, rash, uye kupfupika kwekufema.Kune varwere vane sulfite senitivity, sodium bisulfite-chinhu chiri muRadicava neRadicava ORS-chinogona kukonzera rudzi rwechirwere chinogona kutyisa upenyu.Thekuraira ruzivoinosanganisira mamwe mashoko pamusoro penjodzi dzine chokuita neRadicava ORS.
  • NeChipiri, theFDA's CenteryeDrug Evaluation and Research (CDER) yakazivisa kutangwa kweiyo nyowaniKuwedzera Chirwere Chisina Kurapa (ARC) Chirongwa.Chiono cheCDER's ARC Chirongwa chiri kumhanyisa uye kuwedzera kuvandudzwa kwemaitiro ekurapa akachengeteka uye akachengeteka anogadzirisa izvo zvisingaite zvinodiwa nevarwere vane zvirwere zvisingawanzo.Iri ibasa reCDER-yakafara nehutungamiriri hunomiririrwa kubva kumahofisi akati wandei muCentre yese.Mugore rayo rekutanga, CDER's ARC Chirongwa ichatarisa mukusimbisa kudyidzana kwemukati nekunze nevanobata uye ichabatana nenyanzvi dzekunze kubatsira kuona mhinduro dzezvinetso mukugadzirwa kwezvinodhaka zvisingawanzo.CDER ine tarisiro nezveramangwana rekuvandudzwa kwemishonga yezvirwere zvisingawanzo kugadzirwa uye iri kutarisira kuenderera mberi nebasa rakakosha iri pasi pechirongwa chitsva cheCDER ARC Programme - pamwe chete nevarwere, vachengeti, mapoka evamiriri, vadzidzi, maindasitiri, uye vamwe vanobatana navo - kugadzirisa dambudziko rakakosha rekurapa. zvinodiwa nevarwere nemhuri dzinogara nezvirwere zvisingawanzo.
  • COVID-19 zvigadziriso zvekuongororwa:
    • Kubva nhasi, 432 bvunzo uye sampuli yekuunganidza zvishandiso zvinotenderwa neFDA pasi pemvumo yekushandisa emergency (EUAs).Izvi zvinosanganisira mazana maviri nemakumi mapfumbamwe nemanomwe ebvunzo dzemamorekuru uye sampuli yekuunganidza zvishandiso, makumi masere nemana ekudzivirira muviri uye kumwe bvunzo dzemhinduro dzemuviri, makumi mashanu eantigen bvunzo, uye 1 yekuongorora mweya yekufema.Kune makumi manomwe nenomwe emvumo yemamorekuru uye 1 antibody mvumo inogona kushandiswa nemasampuli akaunganidzwa kumba.Kune 1 EUA yekunyorerwa mishonga kumba, 2 EUAs yeantigen prescription kumba bvunzo, 17 EUAs yeantigen over-the-counter (OTC) kumba bvunzo, uye 3 yemamorekuru OTC pamba bvunzo.
    • Iyo FDA yakabvumidza makumi maviri nemasere maantigen bvunzo uye manomwe mamorekuru bvunzo yeserial screening zvirongwa.Iyo FDA yakabvumidzawo 968 kudzokororwa kumvumo yeEUA.

Related Information

Iyo FDA, agency mukati meUS Dhipatimendi reUtanoneHuman Services, inochengetedza hutano hweveruzhinji nekuvimbisa kuchengetedzwa, kushanda zvakanaka, uye kuchengetedzwa kwemishonga yevanhu neyemhuka, majekiseni uye zvimwe zvigadzirwa zvebiological zvekushandiswa nevanhu, uye midziyo yekurapa.Sangano iri zvakare rinoona nezvekuchengetedza nekuchengetedzeka kwechikafu chenyika yedu, zvekuzora, zvekudya zvinowedzera, zvigadzirwa zvinopa mwaranzi yemagetsi, uye kudzora zvigadzirwa zvefodya.

 


Nguva yekutumira: May-21-2022