Hoʻoikaika ka hana hou i ka holomua.I ka wā e pili ana i ka hana hou i ka hoʻomohala ʻana i nā lāʻau lapaʻau hou a me nā huahana biological therapeutic, kākoʻo ʻo FDA's Center for Drug Evaluation and Research (CDER) i ka ʻoihana lāʻau lapaʻau i kēlā me kēia pae o ke kaʻina hana.Me kona hoʻomaopopo ʻana i ka ʻepekema i hoʻohana ʻia no ka hana ʻana i nā huahana hou, nā kaʻina hana hoʻāʻo a me nā kaʻina hana, a me nā maʻi a me nā kūlana i hoʻolālā ʻia nā huahana hou e mālama, hāʻawi ʻo CDER i nā ʻōlelo aʻo ʻepekema a me nā hoʻoponopono e pono ai e lawe i nā lāʻau lapaʻau hou i ka mākeke.
ʻO ka loaʻa ʻana o nā lāʻau lapaʻau hou a me nā huahana olaola ke ʻano pinepine i nā koho lapaʻau hou no nā maʻi a me ka holomua i ka mālama olakino no ka lehulehu o ʻAmelika.No kēia kumu, kākoʻo ʻo CDER i ka hana hou a he hana koʻikoʻi i ke kōkua ʻana i ka hoʻomohala ʻana i ka lāʻau hou.
I kēlā me kēia makahiki, ʻae ʻo CDER i nā ʻano lāʻau lapaʻau hou a me nā huahana olaola:
1. ʻO kekahi o kēia mau huahana he mau huahana hou i hoʻohana ʻole ʻia i ka hana lapaʻau.Aia ma lalo kahi papa inoa o nā mea molekala hou a me nā huahana olaola therapeutic hou i ʻae ʻia e CDER i 2021. ʻAʻole i loaʻa i kēia papa inoa nā kano, nā huahana allergenic, nā koko a me nā huahana koko, plasma derivatives, cellular and gene therapy products, a i ʻole nā ​​huahana ʻē aʻe i ʻae ʻia ma 2021 e ka Center for Biologics Evaluation and Research.
2. Ua like nā mea ʻē aʻe me nā huahana i ʻae ʻia ma mua, a e hoʻokūkū lākou me kēlā mau huahana ma ka mākeke.E ʻike i ka Drugs@FDA no ka ʻike e pili ana i nā lāʻau lapaʻau a pau a CDER i ʻae ʻia a me nā huahana olaola.
Hoʻokaʻawale ʻia kekahi mau lāʻau lapaʻau ma ke ʻano he hui molekala hou ("NMEs") no nā kumu o ka loiloi FDA.ʻO ka hapa nui o kēia mau huahana i loaʻa nā moieties ikaika ʻaʻole i ʻae ʻia e FDA ma mua, ma ke ʻano he lāʻau hoʻohui hoʻokahi a i ʻole he ʻāpana o ka huahana hui;hāʻawi pinepine kēia mau huahana i nā lāʻau lapaʻau koʻikoʻi no nā maʻi.Hoʻohālikelike ʻia kekahi mau lāʻau lapaʻau ma ke ʻano he NME no nā kumu hoʻomalu, akā naʻe, aia nā moieties ikaika e pili kokoke ana i nā moieties ikaika i nā huahana i ʻae ʻia e FDA.No ka laʻana, hoʻokaʻawale ʻo CDER i nā huahana olaola i waiho ʻia i loko o kahi noi ma lalo o ka pauku 351 (a) o ke Public Health Service Act ma ke ʻano he NME no nā kumu o ka loiloi FDA, me ka nānā ʻole i ka ʻae ʻana o ke Keʻena i kahi moiety hana pili i kahi huahana ʻokoʻa.ʻOkoʻa ka hoʻokaʻawale ʻana o ka FDA i kahi lāʻau ma ke ʻano he "NME" no nā kumu loiloi mai ka hoʻoholo ʻana o ka FDA inā he "hui kemika hou" ka huahana lāʻau a i ʻole "NCE" i loko o ke ʻano o ka Federal Food, Drug, and Cosmetic Act.