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Uthini umahluko phakathi kwamayeza kagqirha kunye namachiza e-OTC?

Ixesha: 2020-05-20 Indawo: 569

Ichiza lichiza elenzelwe ukusetyenziswa kuxilongo, ukunyanga, ukuthomalalisa, unyango, okanye uthintelo lwesifo. Nanku umahluko omkhulu phakathi kwamachiza e-OTC kunye namayeza kagqirha.

Amachiza amiselweyo ngala:Ibhotile yeyeza ebhalwe ngesandla

Ichazwe ngugqirha
Ithengwe ekhemesti
Emiselweyo kwaye ijongwe ukuba isetyenziswe ngumntu omnye
Ukulawulwa yi-FDA ngeNkqubo eNtsha yeSicelo seDrugs (NDA). Eli linyathelo elisesikweni elithathwa ngumxhasi weziyobisi ukubuza ukuba i-FDA ithathele ingqalelo ukuvuma iyeza elitsha ukuze lithengiswe eMelika. I-NDA ibandakanya zonke izilwanyana kunye nedatha yabantu kunye nohlalutyo lwedatha, kunye nolwazi malunga nendlela elisebenza ngayo ichiza emzimbeni kunye nendlela eliveliswa ngayo. Ngolwazi oluthe kratya malunga nenkqubo ye-NDA, nceda ubone "Inkqubo ye-FDA yokuphonononga iziyobisi: Ukuqinisekisa ukuba iziyobisi zikhuselekile kwaye ziyasebenza."
Amachiza e-OTC ngala:Ifoto yeebhotile ezininzi zamayeza

Amachiza ANGAFUNI myalelo kagqirha
Kuthengwe ngaphandle kweshelufu ezivenkileni
Ilawulwa yi-FDA nge-OTC Drug monographs. Iimonographs zamachiza e-OTC luhlobo "lwencwadi yeresiphi" egubungela izithako ezamkelekileyo, iidosi, imixube, kunye nokuleyibhile. Iimonographs ziya kusoloko zihlaziywa zongeza izithako ezongezelelweyo kunye nokuleyibhile njengoko kufuneka. Iimveliso ezihambelana ne-monograph zinokuthengiswa ngaphandle kokuvunyelwa kwe-FDA, ngelixa ezo zingakwenziyo, kufuneka zijongwe ngokwahlukileyo kwaye zivunywe "ngeNkqubo eNtsha yokuVunywa kweChiza."