Elemental Impurities in Animal Drug Products-Questions and Answers; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #255 entitled "Elemental Impurities in Animal Drug Products--Questions and Answers."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.