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Masiku ano, US Food and Drug Administration ikupereka chidule cha nkhani kuchokera ku bungweli:

  • Masiku ano, a FDA adalangiza ogula za kuopsa kwa kumwa mwangozi, makamaka ndi ana, azinthu zodyedwa zomwe zili ndi THC.Kumwa mwangozi zinthu zodyedwazi kungayambitse zovuta zazikulu.
  • Masiku ano, FDAzosindikizidwachitsogozo chomaliza chotchedwa "Kuchepetsa Zowopsa Zachitetezo cha Chakudya cha Microbial popanga Mbewu Zomera: Malangizo Pamakampani.”Chitsogozochi chikuwonetsa nkhawa zomwe a FDA akuda nkhawa nazo pakukula kwa matenda obwera chifukwa cha zakudya zomwe zimagwirizanitsidwa ndi kudya mbewu zosaphika komanso zophikidwa pang'ono ndipo zimapatsa makampani njira zoyenera zopewera chigololo panthawi yonse yopangira mbewu kuti zimere.
  • Lachinayi, FDAadavomereza kutsatsawa zinthu zisanu ndi chimodzi zatsopano za fodya kudzera mu njira ya Premarket Tobacco Product Application (PMTA).FDA idaperekamalamulo operekedwa ndi malonda (MGO)kwa RJ Reynolds Vapor Company chifukwa cha Vuse Vibe yakechipangizo cha e-fodyandi kutsagana ndi fodya wokometsedwa kutsekedwae-liquid pod, komanso chipangizo chake cha e-fodya cha Vuse Ciro ndi fodya wotsekedwae-madzipansi.A FDA adaperekanso malamulo oletsa kutsatsa kwa RJ Reynolds Vapor Company kwa Vuse Vibe ndi Vuse Ciro angapo angapo.mankhwala a e-fodya.Kuphatikiza apo, zinthu zopangidwa ndi menthol zoperekedwa ndi kampaniyo zikadali pansi pa FDA.
  • Lachinayi, a FDA adavomereza kuyimitsidwa pakamwa kwa Radicava ORS (edaravone) pochiza amyotrophic lateral sclerosis (ALS).Radicava ORS ndi mtundu woyendetsedwa pakamwa wa Radicava, womwe unaliidavomerezedwa koyambirira mu 2017 ngati kulowetsedwa kwa mtsempha (IV).Kuchiza ALS, yomwe imatchedwa matenda a Lou Gehrig.Radicava ORS imayendetsedwa yokha ndipo imatha kutengedwa kunyumba.Mukasala kudya usiku wonse, Radicava ORS iyenera kumwedwa m'mawa pakamwa kapena kudzera mu chubu chodyetsera.Mankhwala a pakamwa ali ndi ndondomeko ya dosing yofanana ndi Radicava-mankhwala oyambirira a mlingo wa tsiku ndi tsiku kwa masiku 14, kutsatiridwa ndi masiku a 14 opanda mankhwala ndi mankhwala ochiritsira omwe amakhala ndi mlingo wa tsiku ndi tsiku kwa 10 pa masiku 14, akutsatiridwa. pofika masiku 14 osagwiritsa ntchito mankhwala.Zotsatira zofala kwambiri za Radicava ndizopweteka (kupweteka), mavuto akuyenda (kusokonezeka kwa gait), ndi mutu.Kutopa kumathekanso zotsatira zake kuchokera ku Radicava ORS.Radicava ndi Radicava ORS ikhoza kukhala ndi zotsatira zoyipa zomwe zimagwirizanitsidwa ndi ziwengo kuphatikizapo ming'oma, zidzolo, ndi kupuma movutikira.Kwa odwala omwe ali ndi mphamvu ya sulfite, sodium bisulfite-chomwe chili mu Radicava ndi Radicava ORS-chikhoza kuyambitsa mtundu wa ziwengo zomwe zingakhale zoopsa.TheKufotokozera zambiriikuphatikizanso zambiri pazachiwopsezo chokhudzana ndi Radicava ORS.
  • Lachiwiri, aFDA Centerfor Drug Evaluation and Research (CDER) yalengeza kukhazikitsidwa kwatsopanoKuthamangitsa Pulogalamu ya Rare Disease Cures (ARC)..Masomphenya a CDER's ARC Programme akufulumizitsa ndikukulitsa chitukuko cha njira zochiritsira zogwira mtima komanso zotetezeka pothana ndi zosowa zosakwanira za odwala omwe ali ndi matenda osowa.Uku ndi kuyesayesa kwa CDER ndi utsogoleri woimiridwa kuchokera kumaofesi angapo mu Center.M'chaka chake choyamba, CDER's ARC Programme idzayang'ana kwambiri kulimbikitsa mgwirizano wamkati ndi kunja ndi ogwira nawo ntchito ndipo idzakambirana ndi akatswiri akunja kuti athandize kupeza njira zothetsera mavuto omwe akukumana nawo pa chitukuko cha mankhwala osowa.CDER ikuyembekeza tsogolo la chitukuko cha mankhwala osowa matenda ndipo ikuyembekeza kupitiriza ntchito yofunikayi pansi pa CDER ARC Programme yatsopano - pamodzi ndi odwala, osamalira, magulu olimbikitsa, ophunzira, mafakitale, ndi ogwira nawo ntchito - kuti athetse vuto lalikulu lomwe silinakwaniritsidwe. zosowa za odwala ndi mabanja omwe ali ndi matenda osowa.
  • Zosintha pakuyezetsa COVID-19:
    • Pofika lero, mayeso 432 ndi zida zosonkhanitsira zitsanzo zimaloledwa ndi FDA pansi pa zilolezo zogwiritsa ntchito mwadzidzidzi (EUAs).Izi zikuphatikiza kuyesa kwa mamolekyulu 297 ndi zida zosonkhanitsira zitsanzo, ma antibody 84 ndi mayeso ena okhudzana ndi chitetezo chamthupi, mayeso 50 a antigen, ndi kuyesa kwa mpweya umodzi.Pali zilolezo 77 za mamolekyu ndi chilolezo cha antibody chimodzi chomwe chingagwiritsidwe ntchito ndi zitsanzo zosonkhanitsidwa kunyumba.Pali EUA imodzi yoyezetsa kunyumba, ma EUA 2 oyezetsa kunyumba, ma EUA 17 oyezetsa kunyumba, ndi 3 oyesa kunyumba ndi ma cell a OTC.
    • A FDA avomereza kuyesa kwa antigen 28 ndi kuyesa kwa mamolekyulu 7 pamapulogalamu owunika.A FDA adavomerezanso kukonzanso 968 pazovomerezeka za EUA.

Zambiri Zogwirizana

FDA, bungwe lomwe lili mkati mwa US Department ofThanzindi Human Services, amateteza thanzi la anthu potsimikizira chitetezo, kugwira ntchito, ndi chitetezo cha mankhwala a anthu ndi zinyama, katemera ndi zinthu zina zamoyo zomwe zimagwiritsidwa ntchito ndi anthu, ndi zipangizo zachipatala.Bungweli limayang'aniranso chitetezo ndi chitetezo cha chakudya cha dziko lathu, zodzoladzola, zakudya zopatsa thanzi, zinthu zomwe zimapereka ma radiation amagetsi, komanso kuwongolera fodya.

 


Nthawi yotumiza: May-21-2022