美国FDA 指导原则 CVM GFI 143(VICH GL30)兽药产品药物警戒管制术语清单 英文原版.pdfVIP

#143 Guidance for Industry Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms VICH GL30 Submit comments on this guidance at any time. Submit electronic comments on the guidance to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should be identified with the Docket No. FDA-2002-D-0268 (formerly Docket No. 2002D-0005). For further information regarding this document, contact the Division of Veterinary Product Safety (HFV-240), Office of Surveillance and Compliance, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, Email: CVMAESupport@. Additional copies of this guidance document may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at /AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/u cm123602.htm or U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine October 2014 Contains Non-Binding Recommendations VICH GL30 (PHARMACOVIGILANCE: LIST OF TERMS ) June 2010 For Implementation at Step 7 PHARMACOVIGI