FDA 行业指南：气候带III IV中新兽用药物成分和药物产品的稳定性测试.pdfVIP

#259 Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV VICH GL58 Guidance for Industry Submit comments on this guidance at any time. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2018-D-4662. For further information regarding this document, contact AskCVM@. Additional copies of this guidance document may be requested from the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at either /animal-veterinary or /. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine April 2020 Contains Nonbinding Recommendations VICH GL 58 (QUALITY) - STABILITY: CLIMATIC ZONES III AND IV For adoption at Step 7 Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV Recommended for Adoption at Step 7 of the VICH Process in September 2019 by the VICH Steering Committee This Guidance has been developed by the appropriate VICH Expert Working Group and is subject to consultation