Namhlanje, i-US Food and Drug Administration ibonelela ngesishwankathelo sokujonga nje iindaba ezivela kwi-arhente:

• Namhlanje, i-FDA icebise abathengi malunga nomngcipheko wokusela ngengozi, ngakumbi ngabantwana, beiimveliso ezityiwayo eziqulathe iTHC.Ukungeniswa kwezi mveliso zityiwayo ngempazamo kunokubangela iziganeko ezimbi kakhulu.
• Namhlanje, i-FDA ikhutshiweisikhokelo sokugqibela esithi "Ukunciphisa iiNgcipheko zoKhuseleko loKutya kwiMicimbi yokuVeliswa kweMbewu yokuhluma: IsiKhokelo kuShishino.”Esi sikhokelo sichaza iinkxalabo ezinzulu ze-FDA malunga nokuqhambuka kwezifo ezibangelwa kukutya okunxulumene nokusetyenziswa kwekrwada kunyeiphekwe kancinciiyahluma kwaye ibonelele iifemu ngamanyathelo acetyiswayo okuthintela ukukrexeza kulo lonke ikhonkco lemveliso yembewu ukuze intshule.
• NgoLwesine, i-FDAkugunyaziswe ukuthengisayeemveliso ezintandathu zecuba ezitsha ngendlela yeSicelo seMveliso yeCuba ePhakamileyo (PMTA) indlela.I-FDA ikhutshweiiodolo ezinikwe ukuthengisa (MGO)ukuya kwiNkampani ye-RJ Reynolds Vapor yesixhobo sayo se-e-cigarette i-Vuse Vibe kunye ehamba ne-e-liquid pod enencasa yecuba, kunye nesixhobo sayo se-e-cigarette i-Vuse Ciro kunye necuba elikhaphayo elivaliweyo.i-e-liquid pod.I-FDA ikwakhuphe imiyalelo yokukhanyela ukuthengisa kwiNkampani ye-RJ Reynolds Vapor kwezinye ezininzi iimveliso ze-Vuse Vibe kunye ne-Vuse Ciro e-cigarette.Ukongeza, iiimveliso ezinencasa ye-mentholezingeniswe yinkampani zisephantsi kovavanyo lwe-FDA.
• NgoLwesine, i-FDA ivume i-Radicava ORS (edaravone) ukumiswa komlomo kunyango lwe-amyotrophic lateral sclerosis (ALS).I-Radicava ORS yinguqulelo elawulwa ngomlomo ye-Radicava, eyayiyiyoekuqaleniivunywe ngo-2017 njenge-intravenous(IV) ukunyuswaukunyanga i-ALS, edla ngokubizwa ngokuba sisifo sikaLou Gehrig.I-Radicava ORS ilawulwa ngokwayo kwaye ingathathwa ekhaya.Emva kokuzila ukutya ebusuku, i-Radicava ORS kufuneka ithathwe ekuseni ngomlomo okanye ngombhobho wokutya.Amayeza omlomo ane-dosing regimen efana ne-Radicava-umjikelezo wokuqala wonyango we-dosing yemihla ngemihla yeentsuku ze-14, elandelwa yi-14-day-free-free drug-free kunye nemijikelezo yonyango elandelayo ebandakanya i-dosing yemihla ngemihla ye-10 ngaphandle kweentsuku ze-14, ezilandelwayo. ngeentsuku ezili-14 zamathuba okungabikho kweziyobisi.Iziphumo eziqhelekileyo zecala ze-Radicava ziyi-bruising (i-contusions), iingxaki zokuhamba (ukuphazamiseka kwe-gait), kunye neentloko.Ukukhathala kwakhona yimpembelelo enokwenzeka ye-Radicava ORS.I-Radicava kunye ne-ORS ye-Radicava ingaba nemiphumo emibi kakhulu ehambelana nokuchasana nokuchasana okubandakanya imingxunya, i-rash, kunye nokuphefumula okufutshane.Kwizigulane ezinovakalelo lwe-sulfite, i-sodium bisulfite-isithako kwi-Radicava kunye ne-Radicava ORS-inokuthibangela uhlobo lwe-aleji enokuthi ibeke ubomi esichengeni.Iechaza ulwaziiquka ulwazi olongezelelweyo kwiingozi ezinxulumene ne-Radicava ORS.
• NgoLwesibini, iZiko le-FDA loVavanyo lweZiyobisi kunye noPhando (CDER) libhengeze ukuqaliswa kwentshaUkukhawulezisa iNkqubo yokuNyanga izifo eziBanzi (ARC)..Umbono weNkqubo ye-ARC ye-CDER ikhawulezisa kwaye inyusa uphuhliso lweendlela zonyango ezisebenzayo nezikhuselekileyo ezijongana neemfuno ezingafezekiyo zezigulane ezinezifo ezinqabileyo.Lo ngumzamo obanzi we-CDER kunye neenkokeli ezimelwe kwiiofisi ezininzi kwiZiko lonke.Kunyaka wayo wokuqala, iNkqubo ye-ARC ye-CDER iya kugxila ekomelezeni intsebenziswano yangaphakathi neyangaphandle kunye nabachaphazelekayo kwaye iya kusebenzisana neengcali zangaphandle ukunceda.chonga izisombululokwimingeni kuphuhliso lwamachiza ezifo ezinqabileyo.I-CDER inethemba ngekamva lophuhliso lweziyobisi ezinqabileyo zesifo kwaye ijonge phambili ekuqhubeni lo msebenzi ubalulekileyo phantsi kweNkqubo entsha ye-CDER ARC - kunye nezigulana, abakhathaleli, amaqela axhasayo, izifundiswa, amashishini, kunye namanye amaqabane - ukujongana nezonyango ezingafezekanga. iimfuno zezigulane kunye neentsapho eziphila nezifo ezinqabileyo.
• Uhlaziyo lovavanyo lwe-COVID-19:
  • Ukusukela namhlanje, iimvavanyo ezingama-432 kunye nezixhobo zokuqokelela isampulu zigunyaziswe yi-FDA phantsi kogunyaziso losetyenziso olungxamisekileyo (EUAs).Oku kubandakanya iimvavanyo zemolekyuli ezingama-297 kunye nezixhobo zokuqokelela iisampuli, i-antibody engama-84 kunye nolunye uvavanyo lokuphendula lomzimba, iimvavanyo ze-antigen ezingama-50, kunye novavanyo olu-1 lokuphefumla.Kukho ama-77ugunyaziso lwemolekyulikunye nogunyaziso lwe-antibody olu-1 olunokusetyenziswa kunye neesampuli eziqokelelwe ekhaya.Kukho i-EUA e-1 yovavanyo olumiselweyo lwemolekyuli ekhaya, ii-EUA ezi-2 zovavanyo olumiselweyo lwe-antigen ekhaya, ii-EUA ezili-17 zovavanyo lwe-antigen over-the-counter (OTC) ekhaya, kunye nezi-3 ze-OTC yemolekyuli yasekhaya.
  • I-FDA igunyaze iimvavanyo ze-antigen ze-28 kunye neemvavanyo ze-molekyuli ezi-7 kwiiprogram zokuhlola i-serial.I-FDA ikwagunyazise uhlaziyo lwe-968 kwizigunyaziso ze-EUA.

Ulwazi olunxulumeneyo

I-FDA, i-arhente engaphakathi kwiSebe lezeMpilo kunye neeNkonzo zoLuntu laseMelika, ikhusela impilo yoluntu ngokuqinisekisa ukhuseleko, ukusebenza, kunye nokhuseleko lwamachiza abantu kunye nezilwanyana, izitofu kunye nezinye iimveliso zebhayoloji ezisetyenziselwa ukusetyenziswa ngabantu, kunye nezixhobo zonyango.Le arhente ikwanoxanduva lokhuseleko kunye nokhuseleko lobonelelo lokutya lwesizwe sethu, izithambiso, izongezo zokutya, iimveliso ezikhupha imitha yombane, kunye nokulawula iimveliso zecuba.