Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers; Availability

الملخص

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 211 entitled "Residual Solvents in Animal Drug Products; Questions and Answers." The draft questions and answers (Q&A) guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human and veterinary drugs and to compendial and non- compendial drug products. This document answers questions regarding CVM's implementation of USP Residual Solvents.