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Imprese · 29/11/20101 min di lettura
Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Availability
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Riepilogo
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "ANDAs: Impurities in Drug Products." This guidance updates recommendations regarding degradation products and updates the draft guidance "ANDAs: Impurities in Drug Products" announced in December 1998 in conformance with the revision of the International Conference on Harmonisation (ICH) guidance for industry "Q3B(R) Impurities in New Drug Products," which was announced in August 2006.
Lingua originale della fonte: Federal Register — Health and Human ServicesApri il comunicato originale →