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İş dünyası · 27.03.20181 dk okuma

Elemental Impurities in Animal Drug Products-Questions and Answers; Draft Guidance for Industry; Availability

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Özet

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #255 entitled "Elemental Impurities in Animal Drug Products--Questions and Answers." This guidance is intended to assist sponsors of animal drug products in addressing changes in the United States Pharmacopeia (USP) requirements for the control of elemental impurities in drug products marketed in the United States.

Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →