Uyu munsi, Ubuyobozi bw’ibiribwa n’ibiyobyabwenge muri Amerika buratanga incamake yamakuru aturuka hirya no hino muri iki kigo:

• Uyu munsi, FDA yagiriye inama abakiriya ibyago byo gufatwa nimpanuka, cyane cyane nabana ,.ibicuruzwa biribwa birimo THC.Kwinjira mu buryo butunguranye ibyo bicuruzwa biribwa bishobora gutera ibintu bibi bikomeye.
• Uyu munsi, FDA yatanzweubuyobozi bwa nyuma bwiswe “Kugabanya ingaruka ziterwa n’umutekano wa Microbial mu musaruro wimbuto zimera: Ubuyobozi bwinganda. ”Ubu buyobozi bugaragaza impungenge zikomeye za FDA ku ndwara ziterwa n’ibiribwa ziterwa no kurya mbisi kandibitetse byorohejeimimero kandi itanga firms nintambwe zisabwa kugirango wirinde gusambana murwego rwumusaruro wimbuto kugirango zimera.
• Ku wa kane, FDAyemereye kwamamazay'ibicuruzwa bitandatu bishya by'itabi binyuze mu nzira ya Premarket Itabi ry'ibicuruzwa (PMTA).FDA yatanzekwamamaza byatanze amabwiriza (MGO)kuri RJ Reynolds Vapor Company kubikoresho byayo bya e-itabi rya Vuse Vibe hamwe nuherekeza itabi rya e-fluide ifunze itabi, ndetse no kubikoresho bya e-itabi rya Vuse Ciro hamwe no gufunga uburyohe bwitabi.e-amazi.FDA kandi yatanze amabwiriza yo guhakana ibicuruzwa muri RJ Reynolds Vapor Company kubindi bicuruzwa byinshi bya Vuse Vibe na Vuse Ciro e-itabi.Byongeye kandiibicuruzwa bya mentholcyatanzwe na sosiyete kiracyasuzumwa na FDA.
• Ku wa kane, FDA yemeje Radicava ORS (edaravone) guhagarika umunwa kugirango ivure amyotrophique latal sclerose (ALS).Radicava ORS ni verisiyo yatanzwe mu magambo ya Radicava, yarimu ntangirirobyemejwe muri 2017 nkumuvuduko(IV) gushiramokuvura ALS, bakunze kwita indwara ya Lou Gehrig.Radicava ORS yiyobora kandi irashobora kujyanwa murugo.Nyuma yo kwiyiriza ijoro ryose, Radicava ORS igomba gufatwa mugitondo kumunwa cyangwa binyuze mumiyoboro igaburira.Imiti yo mu kanwa ifite gahunda yo kunywa kimwe na Radicava - uburyo bwo kuvura bwa mbere bwo kunywa buri munsi iminsi 14, bukurikirwa nigihe cyiminsi 14 itarimo ibiyobyabwenge ndetse nubuvuzi bwakurikiranye bugizwe no kunywa buri munsi mugihe 10 muminsi 14, n'iminsi 14 idafite ibiyobyabwenge.Ingaruka zikunze kugaragara kuri Radicava ni ugukomeretsa (contusions), ibibazo byo kugenda (guhungabana gait), no kubabara umutwe.Umunaniro ningaruka zishoboka zituruka kuri Radicava ORS.Radicava na Radicava ORS birashobora kugira ingaruka zikomeye zijyanye na allergique zirimo imitiba, guhubuka, no guhumeka neza.Ku barwayi bafite sensitivite ya sulfite, sodium bisulfite - ibigize muri Radicava na Radicava ORS - birashobokabitera ubwoko bwa allergique reaction ishobora guhitana ubuzima.Uwitekakwandika amakuruikubiyemo amakuru yinyongera kubyerekeye ingaruka zijyanye na Radicava ORS.
• Ku wa kabiri, ikigo cya FDA gishinzwe gusuzuma no gusuzuma ibiyobyabwenge (CDER) cyatangaje ko hashyizwe ahagaragaraKwihutisha Gahunda idasanzwe yo gukiza indwara (ARC).Icyerekezo cya Porogaramu ya ARC ya CDER kirihuta kandi cyongera iterambere ryuburyo bwiza bwo kuvura bukemura ibibazo by’abarwayi bafite indwara zidasanzwe.Nibikorwa bya CDER hamwe nubuyobozi buhagarariwe nibiro byinshi muri Centre.Mu mwaka wambere, Gahunda ya ARC ya CDER izibanda ku gushimangira ubufatanye bwimbere n’imbere n’abafatanyabikorwa kandi buzahuza ninzobere zo hanze zifashamenya ibisubizokubibazo byo guteza imbere imiti idasanzwe.CDER ifite icyizere cy'ejo hazaza h’iterambere ry’ibiyobyabwenge bidasanzwe kandi itegereje gukomeza uyu murimo w’ingenzi muri gahunda nshya ya CDER ARC - hamwe n’abarwayi, abarezi, amatsinda yunganira, abize, inganda, n’abandi bafatanyabikorwa - kugira ngo bakemure ubuvuzi bukomeye butavuwe ibikenewe by'abarwayi n'imiryango ibana n'indwara zidasanzwe.
• COVID-19 ivugurura ryibizamini:
  • Kuva uyu munsi, ibizamini 432 hamwe nicyitegererezo cyo gukusanya byemewe na FDA byemewe nimpushya zo gukoresha byihutirwa (EUAs).Muri byo harimo ibizamini bya molekile 297 hamwe n’ibikoresho byo gukusanya icyitegererezo, antibody 84 n’ibindi bizamini byo gukingira indwara, ibizamini 50 bya antigen, hamwe n’ikizamini cyo guhumeka 1.Hariho 77uburenganzira bwa molekilena antibody 1 yemewe ishobora gukoreshwa hamwe nurugero rwakusanyirijwe murugo.Hariho EUA 1 yo kwipimisha mikorobe murugo, 2 EUAs yo kwandikirwa antigen murugo, 17 EUAs kuri antigen hejuru ya konte (OTC) murugo, na 3 kubizamini bya molekile OTC murugo.
  • FDA yemereye ibizamini 28 bya antigen hamwe na 7 ya molekulari ya porogaramu yo gusuzuma.FDA yemereye kandi 968 ubugororangingo uburenganzira bwa EUA.

Ibisobanuro bijyanye

FDA, ikigo kiri muri Minisiteri y’ubuzima n’ibikorwa by’Amerika muri Amerika, irengera ubuzima bw’abaturage yizeza umutekano, imikorere, n’umutekano w’ibiyobyabwenge by’abantu n’amatungo, inkingo n’ibindi binyabuzima bikoreshwa mu bantu, hamwe n’ibikoresho by’ubuvuzi.Iki kigo kandi gifite inshingano z’umutekano n’umutekano by’igihugu cyacu gitanga ibiribwa, amavuta yo kwisiga, inyongeramusaruro, ibicuruzwa bitanga imirasire ya elegitoroniki, ndetse no kugenzura ibicuruzwa by’itabi.