Zatsopano zimathandizira kupita patsogolo. Zikafika pazatsopano pakupanga mankhwala atsopano ndi mankhwala azitsamba, FDA's Center for Drug Evaluation and Research (CDER) imathandizira makampani opanga mankhwala panjira iliyonse. Ndi kumvetsetsa kwake kwa sayansi yomwe imagwiritsidwa ntchito popanga zinthu zatsopano, kuyesa ndi kupanga njira, komanso matenda ndi mikhalidwe yomwe zinthu zatsopano zimapangidwira, CDER imapereka upangiri wasayansi ndi malamulo ofunikira kuti abweretse mankhwala atsopano pamsika.
Kupezeka kwa mankhwala atsopano ndi zinthu zachilengedwe nthawi zambiri kumatanthauza njira zatsopano zothandizira odwala komanso kupita patsogolo kwa chisamaliro chaumoyo kwa anthu aku America. Pachifukwa ichi, CDER imathandizira zatsopano ndipo imathandizira kupititsa patsogolo chitukuko chatsopano chamankhwala.
Chaka chilichonse, CDER imavomereza mankhwala atsopano osiyanasiyana ndi zinthu zachilengedwe:
1. Zina mwazinthuzi ndi zatsopano zomwe sizinagwiritsidwepo ntchito pazachipatala. Pansipa pali mndandanda wazinthu zatsopano zamamolekyu ndi mankhwala ochizira atsopano ovomerezedwa ndi CDER mu 2021. M'ndandandawu mulibe katemera, zinthu zomwe sizingawonjezeke, magazi ndi zotuluka m'magazi, zotuluka m'madzi a m'magazi, ma cell ndi ma gene therapy, kapena zinthu zina zovomerezedwa mu 2021 ndi Center for Biologics Evaluation and Research.
2. Zina ndizofanana, kapena zokhudzana ndi zinthu zomwe zidavomerezedwa kale, ndipo amapikisana ndi malondawo pamsika. Onani Drugs@FDA kuti mudziwe zambiri zamankhwala onse ovomerezeka a CDER ndi zinthu zachilengedwe.
Mankhwala ena amasankhidwa kukhala magulu atsopano a mamolekyu ("NMEs") pofuna kuwunikanso ndi FDA. Zambiri mwazinthuzi zimakhala ndi zigawo zogwira ntchito zomwe sizinavomerezedwe ndi FDA kale, kaya ngati mankhwala amodzi kapena ngati gawo la mankhwala osakaniza; mankhwalawa nthawi zambiri amapereka zofunika zatsopano mankhwala kwa odwala. Mankhwala ena amadziwika ngati ma NME pazolinga zoyang'anira, komabe amakhala ndi magawo omwe amagwirizana kwambiri ndi zinthu zomwe zidavomerezedwa kale ndi FDA. Mwachitsanzo, CDER imayika m'gulu lazinthu zachilengedwe zomwe zatumizidwa pansi pa ndime 351 (a) ya Public Health Service Act ngati ma NME pofuna kuwunikanso ndi FDA, mosasamala kanthu kuti bungweli lidavomerezapo kale gawo logwirizana ndi chinthu china. Magulu a FDA a mankhwala ngati "NME" kuti awonedwenso ndi osiyana ndi FDA atsimikiza ngati mankhwala ndi "mankhwala atsopano" kapena "NCE" mu tanthauzo la Federal Food, Drug, and Cosmetic Act.