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-FDAikhutshiweisikhokelo 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 nokutyiwa kwezihluma ezikrwada neziphekwe kancinci kwaye sinika 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 yeRJ Reynolds Vapor kwiVuse Vibe yayoisixhobo se-e-cigarettekunye nokukhapha icuba-flavored ivaliwei-e-liquid pod, kunye nesixhobo sayo se-e-cigarette i-Vuse Ciro kunye necuba elikhaphayo elivaliweyoulwelo lwe-eipod.I-FDA ikwakhuphe imiyalelo yokwala ukuthengisa kwiNkampani yeRJ Reynolds Vapor kwezinye ezininzi iVuse Vibe kunye neVuse Ciro.iimveliso ze-e-cigarette.Ukongeza, iimveliso ezinencasa ye-menthol ezingeniswe 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, eyayiyiyoivunywe ekuqaleni kwi-2017 njenge-intravenous (IV) infusionukunyanga i-ALS, edla ngokubizwa ngokuba sisifo sikaLou Gehrig.I-Radicava ORS ilawulwa ngokwayo kwaye ingathathwa ekhaya.Emva kokuzila ukutya ubusuku bonke, 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 ye-14 iintsuku, ilandelwa 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.Imiphumo eqhelekileyo ye-Radicava i-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 ezine-sulfite sensitivity, i-sodium bisulfite-isithako kwi-Radicava kunye ne-Radicava ORS-inokubangela uhlobo lwe-alergic reaction olunokuthi lube yingozi ebomini.Iechaza ulwaziibandakanya ulwazi olongezelelweyo kwiingozi ezinxulumene ne-Radicava ORS.
• NgoLwesibini, iIziko le-FDAyoVavanyo lweZiyobisi kunye noPhando (CDER) yabhengeza ukuphehlelelwa kwentshaUkukhawulezisa iNkqubo yokuNyanga izifo eziBanzi (ARC)..Umbono weNkqubo ye-ARC ye-CDER iyakhawulezisa 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 kugxininisa ekomelezeni intsebenziswano yangaphakathi neyangaphandle kunye nabachaphazelekayo kwaye iya kusebenzisana neengcali zangaphandle ukunceda ukuchonga izisombululo zemingeni ekuphuhlisweni kwamachiza 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 izigunyaziso ze-molekyuli ezingama-77 kunye 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 ngaphakathi kwiSebe lase-US leImpilokunye neeNkonzo zoLuntu, zikhusela impilo yoluntu ngokuqinisekisa ukhuseleko, impumelelo, 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.