Nkhani

FDA ndiye chidule cha Food and Drug Administration (Food and Drug Administration). Mololedwa ndi US Congress, boma la federal, FDA ndiye bungwe lalikulu kwambiri lazamalamulo lomwe limagwira ntchito pazakudya ndi mankhwala. Bungwe la National Health monitoring Agency for Boma la zaumoyo.
Woyang'anira Food and Drug Administration (FDA): Kuyang'anira ndi kuyang'anira zakudya, mankhwala (kuphatikiza mankhwala a Chowona Zanyama), zida zamankhwala, zowonjezera zakudya, zodzoladzola, zakudya zanyama ndi mankhwala osokoneza bongo, vinyo ndi zakumwa zomwe zili ndi mowa wosakwana 7%, ndi zamagetsi. mankhwala; Zogulitsa zomwe zikugwiritsidwa ntchito Kapena ma radiation a ionizing ndi osatulutsa ionizing omwe amapangidwa panthawi yomwe amamwa amakhudza kuyesa, kuyang'anira ndi kutsimikizira zinthu zaumoyo wa anthu ndi chitetezo. Malinga ndi malamulowa, zinthu zomwe tatchulazi ziyenera kuyesedwa ndikutsimikiziridwa ndi FDA zisanagulitsidwe pamsika. FDA ili ndi ufulu wowunika opanga ndikuimba mlandu ophwanya.
Chitsimikizo cha FDA pazida zamankhwala, kuphatikiza: kulembetsa kwa opanga ndi FDA, kulembetsa kwa mankhwala a FDA, kulembetsa mndandanda wazinthu (kulembetsa mafomu 510), kuwunikiranso mndandanda wazinthu ndi kuvomereza (kuwunika kwa PMA), kulemba ndi kusintha kwaukadaulo kwa zida zachipatala, chilolezo chamilandu, kulembetsa, pre-marketing Pa lipoti, zinthu zotsatirazi ziyenera kuperekedwa:
(1) Zinthu zisanu zomalizidwa zonse zapakidwa,
(2) Chithunzi chojambula cha chipangizocho ndi kufotokozera kwake malemba,
(3) The ntchito ndi mfundo ntchito chipangizo;
(4) Chiwonetsero chachitetezo kapena zida zoyesera za chipangizocho,
(5) Chidziwitso pakupanga,
(6) Chidule cha mayesero azachipatala,
(7) Malangizo a mankhwala. Ngati chipangizocho chili ndi mphamvu ya radioactive kapena chimatulutsa zinthu zotulutsa ma radioactive, ziyenera kufotokozedwa mwatsatanetsatane.
Malinga ndi milingo yosiyanasiyana yowopsa, FDA imayika zida zamankhwala m'magulu atatu (I, II, III), gulu lachitatu lomwe lili ndi chiopsezo chachikulu. FDA imafotokoza momveka bwino zamagulu ake azinthu komanso zofunikira pakuwongolera pa chipangizo chilichonse chamankhwala. Ngati chida chilichonse chachipatala chikufuna kulowa mumsika waku US, chikuyenera kuwunikira kaye kagayidwe kazinthu ndi zofunikira pakuwongolera kuti zilembedwe.
Zambiri mwazinthu zitha kuvomerezedwa ndi FDA pambuyo polembetsa mabizinesi, mindandanda yazogulitsa ndikukhazikitsa GMP, kapena mutapereka pulogalamu ya 510(K).