Ƙirƙira tana haifar da ci gaba.Idan ya zo ga ƙirƙira a cikin haɓaka sabbin magunguna da samfuran ilimin halitta, Cibiyar Nazarin Magunguna da Magunguna ta FDA (CDER) tana tallafawa masana'antar harhada magunguna a kowane mataki na tsari.Tare da fahimtar ilimin kimiyya da aka yi amfani da shi don ƙirƙirar sababbin samfurori, gwaje-gwaje da hanyoyin masana'antu, da cututtuka da yanayin da aka tsara sababbin samfurori don magance, CDER yana ba da shawarar kimiyya da ka'idoji da ake bukata don kawo sababbin hanyoyin kwantar da hankali ga kasuwa.
Samuwar sabbin magunguna da samfuran halitta galibi yana nufin sabbin zaɓuɓɓukan jiyya ga marasa lafiya da ci gaban kiwon lafiya ga jama'ar Amurka.Saboda wannan dalili, CDER yana goyan bayan ƙididdigewa kuma yana taka muhimmiyar rawa wajen taimakawa wajen ci gaba da sababbin ci gaban ƙwayoyi.
Kowace shekara, CDER ta amince da sabbin magunguna da samfuran halittu masu yawa:
1. Wasu daga cikin waɗannan samfuran sabbin samfura ne waɗanda ba a taɓa amfani da su ba a aikin asibiti.Da ke ƙasa akwai jerin sabbin mahaɗan kwayoyin halitta da sabbin samfuran ilimin halitta waɗanda CDER ta amince da su a cikin 2021. Wannan jeri ɗin ba ya ƙunshi alluran rigakafi, samfuran allergenic, samfuran jini da jini, abubuwan da ke haifar da plasma, samfuran salon salula da samfuran jiyya, ko wasu samfuran da aka amince da su a cikin 2021 ta hanyar 2021. Cibiyar Nazarin Halittu da Bincike.
2. Wasu iri ɗaya ne da, ko alaƙa da samfuran da aka amince da su a baya, kuma za su yi gogayya da waɗannan samfuran a kasuwa.Dubi Drugs@FDA don bayani game da duk magungunan da CDER ta amince da su da samfuran halitta.
Ana rarraba wasu magunguna azaman sabbin mahaɗan kwayoyin halitta ("NMEs") don dalilai na bita na FDA.Yawancin waɗannan samfuran sun ƙunshi ƙungiyoyi masu aiki waɗanda FDA ba ta amince da su a baya ba, ko dai azaman sinadarai guda ɗaya ko a matsayin wani ɓangare na samfuran haɗin gwiwa;waɗannan samfuran akai-akai suna ba da mahimman sabbin hanyoyin kwantar da hankali ga marasa lafiya.Wasu magungunan ana siffanta su azaman NMEs don dalilai na gudanarwa, amma duk da haka sun ƙunshi ƙungiyoyi masu aiki waɗanda ke da alaƙa ta kud da kud da ƙungiyoyi masu aiki a cikin samfuran waɗanda FDA ta amince da su a baya.Misali, CDER tana rarraba samfuran halitta waɗanda aka ƙaddamar a cikin aikace-aikacen ƙarƙashin sashe na 351 (a) na Dokar Sabis na Kiwon Lafiyar Jama'a azaman NMEs don dalilai na bita na FDA, ko da a baya Hukumar ta amince da wani abu mai alaƙa a cikin wani samfuri daban.Rarraba FDA na magani a matsayin "NME" don dalilai na bita ya bambanta da ƙudirin FDA na ko samfurin magani shine "sabon mahaɗan sinadarai" ko "NCE" a cikin ma'anar Dokar Abinci, Drug, da Cosmetic ta Tarayya.