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Imprese · 22/07/19991 min di lettura
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL11 Draft Guidance on Impurities in New Veterinary Medicinal Products; Availability; Request for Comments
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA) is announcing the availability for comment of a draft guidance developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH GL11 draft guidance for industry entitled ``Impurities in New Veterinary Medicinal Products'' provides guidance recommendations for applications for marketing authorizations on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesized new active substances not previously registered in a member state.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →