Guhanga udushya bitera iterambere. Ku bijyanye no guhanga udushya mu guteza imbere imiti mishya n’ibicuruzwa bivura ibinyabuzima, Ikigo cya FDA gishinzwe gusuzuma no gusuzuma ibiyobyabwenge (CDER) gishyigikira inganda z’imiti kuri buri ntambwe. Hamwe no gusobanukirwa siyanse ikoreshwa mugukora ibicuruzwa bishya, gupima no gukora inzira, hamwe nindwara nibicuruzwa bishya bigenewe kuvura, CDER itanga inama zubumenyi nubuyobozi bukenewe kugirango ubuvuzi bushya 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 mu gufasha guteza imbere ibiyobyabwenge bishya.
Buri mwaka, CDER yemeza ibiyobyabwenge byinshi 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, ibikomoka ku maraso n’amaraso, ibikomoka kuri plasma, ibikomoka kuri selile na gene, cyangwa ibindi bicuruzwa byemejwe mu 2021 na Ikigo gishinzwe gusuzuma no gusuzuma ibinyabuzima.
2. Abandi ni kimwe, cyangwa bifitanye isano nibicuruzwa byemewe mbere, kandi bazahatana nibicuruzwa kumasoko. Reba Ibiyobyabwenge @ FDA kugirango umenye amakuru yerekeye imiti yose yemewe ya CDER nibicuruzwa byibinyabuzima.
Imiti imwe n'imwe ishyirwa mubintu bishya ("NMEs") hagamijwe gusuzuma FDA. Byinshi muri ibyo bicuruzwa birimo imyuka ikora itemewe na FDA mbere, haba nk'umuti umwe wibigize cyangwa nkigice cyibicuruzwa bivanze; ibyo bicuruzwa akenshi bitanga imiti mishya kubarwayi. Ibiyobyabwenge bimwe birangwa na NMEs kubikorwa byubuyobozi, ariko nonese birimo moities zifitanye isano rya hafi na moities ikora mubicuruzwa byemejwe mbere na FDA. Kurugero, CDER ishyira mubikorwa ibinyabuzima byatanzwe mubisabwa hakurikijwe ingingo ya 351 (a) y itegeko rigenga serivisi zubuzima rusange nka NMEs hagamijwe gusuzuma FDA, tutitaye ko Ikigo cyabanje kwemeza umuvuduko ukabije mubicuruzwa bitandukanye. Kuba FDA ishyira ibiyobyabwenge nka "NME" mu rwego rwo gusuzuma biratandukanye n’uko FDA yemeje niba ibicuruzwa by’ibiyobyabwenge ari "uruganda rushya rw’imiti" cyangwa "NCE" mu bisobanuro by’amategeko agenga ibiribwa, ibiyobyabwenge, no kwisiga.