Namuhla, i-US Food and Drug Administration ihlinzeka ngesifinyezo sezindaba ezivela kuyo yonke i-ejensi:

• Namuhla, i-FDA yeluleke abathengi mayelana nobungozi bokugwinya ngengozi, ikakhulukazi izingane, zeimikhiqizo edliwayo equkethe iTHC.Ukungena ngephutha kwale mikhiqizo edliwayo kungase kubangele izehlakalo ezimbi kakhulu.
• Namuhla, i-FDAikhishweisiqondiso sokugcina esinesihloko esithi “Ukunciphisa Izingozi Zokuphepha Kokudla Kwamagciwane Ekukhiqizeni Imbewu Ukuze Ihlume: Isiqondiso Semboni.”Lesi siqondiso sibonisa ukukhathazeka okukhulu kwe-FDA ngokuqubuka kwezifo ezibangelwa ukudla okuhlobene nokusetshenziswa kwezithombo eziluhlaza naphekwe kancane futhi sinikeza amafemu izinyathelo ezinconyiwe zokuvimbela ukuphinga kulo lonke uchungechunge lokukhiqiza lwembewu ukuze luhlume.
• NgoLwesine, i-FDAigunyaze ukumakethayemikhiqizo emisha eyisithupha kagwayi ngokusebenzisa indlela ye-Premarket Tobacco Product Application (PMTA).I-FDA ikhishweama-oda anikezwe ukuthengisa (MGO)ku-RJ Reynolds Vapor Company ngeVuse Vibe yayoidivayisi ye-e-cigarettefuthi okuhambisana nogwayi okunambitheka okuvaliwei-e-liquid pod, kanye nedivayisi yayo ye-e-cigarette ye-Vuse Ciro kanye ne-flavour ehambisana nogwayi evaliwei-e-liquidi-pod.I-FDA iphinde yakhipha imiyalo yokwenqaba ukumaketha ku-RJ Reynolds Vapor Company kwezinye i-Vuse Vibe kanye ne-Vuse Ciro.imikhiqizo ye-e-cigarette.Ukwengeza, imikhiqizo enambitheka ye-menthol ehanjiswe yinkampani isangaphansi kokubuyekezwa kwe-FDA.
• NgoLwesine, i-FDA igunyaze ukumiswa ngomlomo kwe-Radicava ORS (edaravone) ukuze zelashwe i-amyotrophic lateral sclerosis (ALS).I-Radicava ORS inguqulo elawulwa ngomlomo ye-Radicava, eyayikhonayavunywa ekuqaleni ngo-2017 njengokufakwa kwe-intravenous (IV).ukwelapha i-ALS, evame ukubizwa ngokuthi isifo sikaLou Gehrig.I-Radicava ORS iyazilawula futhi ingathathwa ekhaya.Ngemva kokuzila ukudla ebusuku, i-Radicava ORS kufanele iphuzwe ekuseni ngomlomo noma ngeshubhu lokuphakela.Imithi yomlomo inomuthi ofanayo we-dosing njenge-Radicava-umjikelezo wokuqala wokwelapha we-dosing nsuku zonke izinsuku ezingu-14, okulandelwa isikhathi sezinsuku ezingu-14 ngaphandle kwezidakamizwa kanye nemijikelezo yokwelashwa elandelayo ehlanganisa umthamo wansuku zonke wezinsuku eziyi-10 kweziyi-14, ezilandelwayo. ngezikhathi eziyi-14 zokungabi nazidakamizwa.Imiphumela emibi evame kakhulu ye-Radicava i-bruising (i-contusions), izinkinga zokuhamba (ukuphazamiseka kwe-gait), kanye nekhanda.Ukukhathala nakho kungaba umphumela ongase ube khona we-Radicava ORS.I-Radicava ne-Radicava ORS ingaba nemiphumela emibi kakhulu ehambisana nokungezwani komzimba okuhlanganisa ukuqubuka, ukuqubuka, nokuphelelwa umoya.Ezigulini ezinokuzwela kwe-sulfite, i-sodium bisulfite—isithako ku-Radicava ne-Radicava ORS—ingabangela uhlobo lokungezwani komzimba okungase lubeke ukuphila engozini.Iechaza ulwaziihlanganisa ulwazi olwengeziwe ngezingozi ezihlobene ne-Radicava ORS.
• NgoLwesibili, i-Isikhungo se-FDAye-Drug Evaluation and Research (CDER) imemezele ukwethulwa okushaUkusheshisa Uhlelo Lokwelapha Izifo Ezingavamile (i-ARC)..Umbono woHlelo lwe-ARC lwe-CDER uyasheshisa futhi ukhulisa ukuthuthukiswa kwezindlela zokwelapha eziphumelelayo neziphephile ezibhekana nezidingo ezingahlangatshezwana neziguli ezinezifo ezingandile.Lona umzamo obanzi we-CDER enobuholi obumelwe emahhovisi amaningana kuso sonke iSikhungo.Onyakeni walo wokuqala, Uhlelo lwe-ARC lwe-CDER luzogxila ekuqiniseni ubudlelwano bangaphakathi nabangaphandle nababambiqhaza futhi luzoxoxisana nochwepheshe bangaphandle ukuze basize ekutholeni izixazululo zezinselele zokuthuthukiswa kwemithi yezifo ezingandile.I-CDER inethemba ngekusasa lokuthuthukiswa kwezidakamizwa zezifo ezingavamile futhi ibheke ngabomvu ukuqhubeka nalo msebenzi obalulekile ngaphansi kohlelo olusha lwe-CDER ARC - kanye neziguli, abanakekeli, amaqembu akhulumela, izifundiswa, izimboni, nabanye ozakwethu - ukubhekana nezinkinga ezibalulekile zezokwelapha ezingakahlangatshezwana nazo. izidingo zeziguli nemindeni ephila nezifo ezingandile.
• Izibuyekezo zokuhlolelwa i-COVID-19:
  • Kusukela namuhla, izivivinyo ezingama-432 namadivayisi wokuqoqa amasampula agunyazwe yi-FDA ngaphansi kokugunyazwa kokusetshenziswa kwezimo eziphuthumayo (ama-EUAs).Lokhu kufaka phakathi ukuhlolwa kwamangqamuzana angama-297 kanye nemishini yokuqoqa amasampula, ama-antibody angama-84 nokunye ukuhlolwa kokusabela komzimba, ukuhlolwa kwama-antigen angama-50, kanye nokuhlolwa kokuphefumula okukodwa.Kukhona ukugunyazwa kwamangqamuzana angama-77 kanye nokugunyazwa kwe-antibody oku-1 okungasetshenziswa namasampula aqoqwe ekhaya.Kukhona i-EUA engu-1 yokuhlolwa kwemithi ye-molecular ekhaya, ama-EUA angu-2 okuhlolwa kwemithi ye-antigen ekhaya, ama-EUA angu-17 okuhlolwa kwe-antigen over-the-counter (OTC) ekhaya, kanye no-3 okuhlolwa kwe-molecular OTC ekhaya.
  • I-FDA igunyaze ukuhlolwa kwe-antigen okungu-28 kanye nokuhlolwa kwamangqamuzana angu-7 ngezinhlelo zokuhlola eziwuchungechunge.I-FDA iphinde yagunyaza ukubuyekezwa okungu-968 kokugunyazwa kwe-EUA.

Ulwazi Oluhlobene

I-FDA, i-ejensi engaphakathi koMnyango wase-USImpilokanye Nemisebenzi Yabantu, ivikela impilo yomphakathi ngokuqinisekisa ukuphepha, ukusebenza kahle, nokuvikeleka kwemithi yabantu neyezilwane, imigomo kanye neminye imikhiqizo yebhayoloji ezosetshenziswa abantu, kanye nemishini yezokwelapha.I-ejensi futhi inesibopho sokuphepha nokuvikeleka kokuhlinzekwa kokudla kwesizwe sakithi, izimonyo, izithasiselo zokudla, imikhiqizo ekhipha imisebe ye-electronic, kanye nokulawula imikhiqizo kagwayi.