Iindaba

I-FDA sisishunqulelo soLawulo lokuTya kunye neDrugs (uLawulo lokuTya kunye neDrugs).Igunyaziswe yiCongress yase-US, urhulumente wobumbano, i-FDA yeyona arhente yonyanzeliso lomthetho igxile ekulawuleni ukutya kunye neziyobisi.I-arhente yezempilo yesizwe yolawulo lwezempilo.
Umphathi woLawulo lokuTya kunye neDrugs (i-FDA): Ukongamela kunye nokuhlolwa kokutya, iziyobisi (kubandakanywa neziyobisi zezilwanyana), izixhobo zonyango, izongezo zokutya, izithambiso, ukutya kwezilwanyana kunye neziyobisi, iwayini kunye neziselo ezinxilisayo ezingaphantsi kwe-7%, kunye ne-elektroniki. iimveliso;iimveliso ezisetyenziswayo Okanye i-ionizing kunye ne-non-ionizing radiation eyenziwe kwinkqubo yokusetyenziswa ichaphazela uvavanyo, ukuhlolwa kunye nokuqinisekiswa kwezinto zempilo yabantu kunye nokhuseleko.Ngokwemigaqo, ezi mveliso zikhankanywe ngasentla kufuneka zivavanywe kwaye zingqinwe zikhuselekile yi-FDA phambi kokuba zithengiswe emarikeni.I-FDA inelungelo lokuhlola abavelisi kunye nokutshutshisa abo baphula umthetho.
Isiqinisekiso se-FDA sezixhobo zonyango, kubandakanywa: ukubhaliswa komvelisi kunye ne-FDA, ukubhaliswa kwemveliso ye-FDA, ukubhaliswa koluhlu lwemveliso (ukubhaliswa kwefom ye-510), ukuhlaziywa koluhlu lwemveliso kunye nokuvunywa (ukuhlaziywa kwe-PMA), ukubhaliswa kunye nokuguqulwa kobugcisa bezixhobo zempilo, ukuhlanjululwa kwezithethe, ukubhaliswa, ukuthengiswa kwangaphambili Ukwenzela ingxelo, ezi zixhobo zilandelayo mazingeniswe:
(1) Iimveliso ezintlanu ezigqityiweyo zipakishwe,
(2) Umzobo wesakhiwo sesixhobo kunye nenkcazo yesicatshulwa,
(3) Umgaqo wokusebenza kunye nokusebenza kwesixhobo;
(4) Umboniso wokhuseleko okanye izixhobo zokuvavanya isixhobo,
(5) Intshayelelo kwinkqubo yokwenziwa kwemveliso,
(6) Isishwankathelo solingo lwezonyango,
(7) Imiyalelo yemveliso.Ukuba ifowuni inamandla e-radioactive okanye ikhupha izinto ezine-radioactive, kufuneka ichazwe ngokweenkcukacha.
Ngokwamanqanaba ahlukeneyo engozi, i-FDA ihlela izixhobo zonyango kwiindidi ezintathu (I, II, III), kunye nodidi lwe-III olunomngcipheko ophezulu.I-FDA ichaza ngokucacileyo ukuhlelwa kwemveliso kunye neemfuno zokulawula kwisixhobo ngasinye sonyango.Ukuba nasiphi na isixhobo sonyango sifuna ukungena kwimarike yase-US, kufuneka kuqala icacise ulwahlulo lwemveliso kunye neemfuno zolawulo loluhlu.
Uninzi lweemveliso zinokuvunywa yi-FDA emva kokubhaliswa kweshishini, uluhlu lwemveliso kunye nokuphunyezwa kwe-GMP, okanye emva kokungenisa isicelo se-510 (K).