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

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #255 entitled "Elemental Impurities in Animal Drug Products--Questions and Answers." This guidance provides recommendations to sponsors regarding the control of elemental impurities in animal drug products, including all dosage forms and routes of administration.