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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 FDA rakabudiswanhungamiro yekupedzisira ine musoro unoti "Kuderedza Njodzi Dzinochengeteka Kwekudya Mukugadzirwa kweMbeu Yekumera: Kutungamira kuIndasitiri.”Nhungamiro iyi inotsanangura kushushikana kwakanyanya kweFDA pamusoro pechirwere chekudya chinobuda chine chekuita nekushandiswa kwembishi uyeyakabikwa zvishomainomera uye inopa mafemu matanho anokurudzirwa kudzivirira hupombwe mukati mechikamu chekugadzirwa 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 e-fodya yefodya uye inoperekedza fodya-inonhuhwirira yakavharwa e-liquid pod, pamwe neiyo Vuse Ciro e-fodya yefodya uye inoperekedza fodya-yakanaka yakavharwa.e-liquid pod.Iyo FDA yakapawo mirairo yekuramba kushambadzira kuRJ Reynolds Vapor Kambani yezvimwe zvakawanda zvigadzirwa zveVuse Vibe neVuse Ciro e-fodya.Mukuwedzera, iyomenthol-flavored productszvakatumirwa nekambani zvichiri pasi pekuongorora kweFDA.
  • Nemusi weChina, iyo FDA yakabvumidza Radicava ORS (edaravone) kumiswa nemuromo kurapwa kweamyotrophic lateral sclerosis (ALS).Radicava ORS ishanduro inopihwa nemuromo yeRadicava, yaivepakutangayakabvumidzwa 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 uye Radicava ORS—inogonakukonzera rudzi rweallergic reaction inogona kutyisa hupenyu.Thekuraira ruzivoinosanganisira mamwe mashoko pamusoro penjodzi dzine chokuita neRadicava ORS.
  • NeChipiri, iyo FDA's Center for Drug 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.kuziva mhinduronokuda kwezvinetso mukukura kwemishonga isingawanzoitiki.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 77mamolecular mvumouye mvumo 1 yekurwisa masoja ayo anogona 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, sangano riri mukati meUS Department of Health and Human Services, inochengetedza hutano hweveruzhinji nekuvimbisa kuchengetedzwa, kushanda, uye kuchengetedzeka kwemishonga yevanhu neyemhuka, majekiseni uye zvimwe zvigadzirwa zvebiological zvekushandisa kwevanhu, uye michina yekurapa.Sangano iri zvakare rinoona nezvekuchengetedza nekuchengetedzeka kwechikafu chenyika yedu, zvekuzora, zvekudya zvinowedzera, zvigadzirwa zvinopa mwaranzi yemagetsi, uye kudzora zvigadzirwa zvefodya.

 


Nguva yekutumira: May-17-2022