Guhanga udushya bitera imbere.Ku bijyanye no guhanga udushya mu guteza imbere imiti mishya n’ibicuruzwa bivura ibinyabuzima, Ikigo cya FDA gishinzwe gusuzuma no gukora ubushakashatsi (CDER) gishyigikira inganda zimiti kuri buri ntambwe.Hamwe no gusobanukirwa siyanse ikoreshwa mugukora ibicuruzwa bishya, kugerageza no gukora, hamwe nindwara nibintu ibicuruzwa bishya bigenewe kuvura, CDER itanga inama zubumenyi nubuyobozi bukenewe kugirango ubuvuzi bushya bugere ku isoko.
Kuboneka imiti mishya nibicuruzwa byibinyabuzima bisobanura uburyo bushya bwo kuvura abarwayi niterambere ryubuvuzi kubanyamerika.Kubera iyo mpamvu, CDER ishyigikira udushya kandi igira uruhare runini mugufasha guteza imbere ibiyobyabwenge bishya.
Buri mwaka, CDER yemeza imiti myinshi nibinyabuzima:
1. Bimwe muri ibyo bicuruzwa nibicuruzwa bishya bitigeze bikoreshwa mubikorwa byubuvuzi.Hano hepfo urutonde rwibintu bishya bya molekuline nibicuruzwa bishya bivura biologiya byemejwe na CDER mu 2021. Uru rutonde ntirurimo inkingo, ibicuruzwa bya allergique, amaraso n’amaraso, ibikomoka kuri plasma, ibikomoka kuri selile na gene, cyangwa ibindi bicuruzwa byemejwe muri 2021 na Ikigo gishinzwe gusuzuma ibinyabuzima nubushakashatsi.
2. Abandi ni kimwe, cyangwa bifitanye isano, ibicuruzwa byemewe mbere, kandi bazahatanira ibyo bicuruzwa kumasoko.Reba Ibiyobyabwenge @ FDA kugirango umenye amakuru yimiti yose yemewe na CDER nibinyabuzima.
Imiti imwe n'imwe ishyirwa mubintu bishya bya molekile ("NMEs") hagamijwe gusuzuma FDA.Byinshi muri ibyo bicuruzwa birimo ibintu bikora bitemewe na FDA mbere, haba nk'ibiyobyabwenge kimwe cyangwa igice cyibicuruzwa bivanze;ibyo bicuruzwa akenshi bitanga imiti mishya kubarwayi.Ibiyobyabwenge bimwe birangwa na NMEs kubikorwa byubuyobozi, ariko nonese birimo moieties ikora ifitanye isano rya hafi nimikorere ikora mubicuruzwa byemejwe mbere na FDA.Kurugero, CDER ishyira mubikorwa ibinyabuzima byatanzwe mubisabwa munsi yingingo ya 351 (a) y itegeko rigenga serivisi zubuzima rusange nka NMEs hagamijwe gusuzuma FDA, tutitaye ko Ikigo cyabanje kwemeza ibikorwa bifitanye isano nibicuruzwa bitandukanye.Icyiciro cya FDA cyo gushyira ibiyobyabwenge nka "NME" mu rwego rwo gusuzuma biratandukanye n’icyemezo cya FDA cyo kumenya niba ibiyobyabwenge ari "imiti mishya" cyangwa "NCE" mu bisobanuro by’amategeko agenga ibiryo, ibiyobyabwenge, no kwisiga.