Hukumar kula da lafiya ta Amurka ta ba da shawarar masu haɓaka maganin cutar kansa a mafi yawan lokuta suna gudanar da gwaje-gwaje masu tsauri don neman amincewar ɗan takararsu.
Shawarar da Hukumar Abinci da Magunguna ta gabatar ta biyo bayan zargi don ingantaccen hanyar amincewa, da kuma sake nazarin tarayya mai zaman kanta a ciki bayan takaddamar nod na Biogen Inc’s (BIIB.O) maganin Alzheimer Aduhelm.
Amincewa da hukumar ta baiwa hukumar damar matsar da hanyoyin kwantar da tarzoma wadanda ke da nasaba da munanan yanayi da kuma barazana ga rayuwa zuwa kasuwa cikin gaggawa amma an sha suka saboda wasu magunguna daga baya an tabbatar da cewa ba su da inganci.
FDA ta ba da shawarar cewa kamfanoni su gudanar da gwaje-gwajen sarrafawa wanda marasa lafiya ke karɓar ko dai magani ko wani madadin magani maimakon gwaje-gwajen da ke gwada maganin ba tare da kwatancen ba, wanda aka sani da nazarin hannu guda.
Ana iya gudanar da karatun hannu daya a wasu lokuta, amma ana bukatar tattaunawa da hukumar tukuna, in ji shi.
“Idan aka ba da iyakokin gwaje-gwajen hannu guda ɗaya, gwajin gwagwarmayar da bazuwar ita ce hanyar da aka fi so don tallafawa aikace-aikacen don saurin amincewa,” in ji FDA.
Masu haɓaka magungunan ƙwayoyi waɗanda suka ƙaddamar da nazarin “hannu ɗaya” don samun saurin amincewa yawanci suna gudanar da gwaji daban bayan amincewa don tabbatar da fa’idodin asibiti.
Mai gudanarwa ya ba da shawarar hanyoyi guda biyu – ɗaya na gudanar da gwaji na asibiti bazuwar kafin samun hanzarin nod sannan kuma don tabbatar da fa’idodin, da kuma wani na riƙe da gwaji ɗaya kawai don neman nod tare da bin dogon lokaci.
Gudun gwaji guda ɗaya na bazuwar yana da fa’idar samar da saurin tabbatar da fa’idodin, in ji FDA.
A cikin ‘yan shekarun da suka wuce, Merck & Co Inc’s (MRK.N) izinin Keytruda a matsayin magani ga wasu masu ciwon huhu na huhu an janye baya kuma an cire maganin lymphoma na TG Therapeutics Inc’s (TGTX.O). Wadanda aka hanzarta amincewa sun dogara ne akan binciken hannu guda.
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