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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, FDA zosindikizidwachitsogozo chomaliza chotchedwa "Kuchepetsa Zowopsa Zachitetezo cha Chakudya cha Microbial popanga Mbewu Zomera: Malangizo Pamakampani.”Chitsogozochi chikuwonetsa zodetsa nkhawa za FDA pakukula kwa matenda obwera chifukwa cha zakudya zomwe zimagwirizanitsidwa ndi kumwa yaiwisi ndizophikidwa mopepukaimamera ndikupatsa makampani njira zovomerezeka zopewera chigololo panthawi yonse yopanga mbewu kuti zimere.
  • Lachinayi, FDAadavomereza malondawa 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 chipangizo chake cha e-fodya cha Vuse Vibe komanso poto yotsekedwa ndi fodya, komanso chipangizo chake cha Vuse Ciro e-fodya ndi fodya wotsekedwa.e-liquid pod.A FDA adaperekanso malamulo oletsa kutsatsa kwa RJ Reynolds Vapor Company pazinthu zina zingapo za Vuse Vibe ndi Vuse Ciro e-fodya.Kuphatikiza apo, themankhwala opangidwa ndi mentholzoperekedwa 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 unalipoyambiriraidavomerezedwa mu 2017 ngati intravenous(IV) kulowetsedwaKuchiza 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 (kusokonezeka), 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 vuto la sulfite, sodium bisulfite-chomwe chili mu Radicava ndi Radicava ORS-chikhozakuyambitsa mtundu wa ziwengo zomwe zitha kuyika moyo pachiswe.TheKufotokozera zambiriikuphatikizanso zambiri pazachiwopsezo chokhudzana ndi Radicava ORS.
  • Lachiwiri, a FDA's Center for Drug Evaluation and Research (CDER) adalengeza 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.zindikirani njira zothetserapazovuta za chitukuko cha matenda 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 77zilolezo za maselondi chilolezo cha antibody 1 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 avomerezanso kukonzanso 968 ku zovomerezeka za EUA.

Zambiri Zogwirizana

A FDA, bungwe la US Department of Health and Human Services, limateteza thanzi la anthu powatsimikizira chitetezo, kuchita bwino, ndi chitetezo chamankhwala a anthu ndi ziweto, katemera ndi zinthu zina zachilengedwe zogwiritsidwa ntchito ndi anthu, ndi zida zamankhwala.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-17-2022