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İş dünyası · 29.11.20101 dk okuma
Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Availability
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Özet
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 This guidance updates recommendations regarding degradation products and updates the draft guidance "ANDAs: Impurities in Drug Products" announced in December 1998 in conformance with the revision of the International Conference on Harmonisation (ICH)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.
Kaynağın orijinal dili: Federal Register — Health and Human ServicesOrijinal duyuruyu açın →