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Nguwuphi umahluko phakathi kwamayeza amiselweyo kunye neziyobisi ze-OTC?

Ixesha: 2020-05-20 Indawo: 123

Iyeza yinto ekujongwe ukuba isetyenziselwe ukuxilonga, ukunyanga, ukunciphisa, unyango okanye ukuthintela izifo. Nanku umahluko ophambili phakathi kwamachiza e-OTC kunye neziyobisi.

Amachiza amiselweyo: Ukubamba ngesandla ibhotile yeziyobisi

Umiselwe ngugqirha
Kuthengwe ekhemesti
Imiselwe kwaye yenzelwe ukuba isetyenziswe ngumntu omnye
Imiselwe yi-FDA ngenkqubo eNtsha yokuSebenzisa iziyobisi (NDA). Eli linyathelo elisemthethweni elixhaswa ngabaxhasi beziyobisi ukubuza ukuba i-FDA ithathele ingqalelo ukwamkela ichiza elitsha lokuthengisa eMelika. I-NDA ibandakanya yonke idatha yezilwanyana kunye neyabantu kunye nohlalutyo lwedatha, kunye nolwazi malunga nokuba ichiza liziphatha njani emzimbeni kwaye lenziwa njani. Ngolwazi oluthe kratya malunga nenkqubo ye-NDA, nceda ubone "Inkqubo yokuHlola iziyobisi ye-FDA: Ukuqinisekisa ukuba iziyobisi zikhuselekile kwaye ziyasebenza."
Iziyobisi ze-OTC zezi: Ifoto yeebhotile ezininzi zamayeza

Iziyobisi ezingafuneki ngugqirha
Kuthengwe ngaphandle kweshelufa ezivenkileni
Imiselwe yi-FDA ngokusebenzisa ii-OTC iziyobisi. Ii-monographs ze-OTC zeziyobisi ziluhlobo "lwencwadi yeeresiphi" egubungela izithako ezamkelekileyo, idosi, ukwenziwa kunye neelebheli. IiMonographs ziya kuqhubeka zihlaziywa zongeza ezinye izithako kunye neelebheli njengoko kufuneka. Iimveliso ezingqinelana ne-monograph zinokuthengiswa ngaphandle kwemvume ye-FDA, ngelixa ezo zingakwenziyo, kufuneka ziphonononge zahlukile kwaye zivunywe yiNkqubo eNtsha yokuVunywa kweziyobisi.