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Table of Contents
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CVM Update
Federal Register Notices
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Interim Final Rule - Docket No. 88N-0038, CVM 200254. Records and Reports Concerning Experience with Approved New Animal Drugs; Delay of Effective Date. Page 49568 [FR Doc. 02-19299] July 31, 2002 | htm | | pdf | Effective date delayed indefinitely
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Interim Final Rule - Docket No. 88N-0038, OC 2094220. Records and Reports Concerning Experience with Approved New Animal Drugs. Pages 5046-–5061 [FR Doc. 02-02549] February 4, 2002 | htm | | pdf |
Comments by April 5, 2002 Effective August 5, 2002
CVM Program Policy and Procedures Manual
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1240.3510 - Drug Experience Reporting Requirements, February 20, 2007
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1240.3512 - Additional Sources of Adverse Reaction and Injury Reports, February 20, 2007
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1240.3514 - Drug Experience Reporting by Veterinarians, February 20, 2007
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1240.3520 - Adverse Reactions as a Basis for Regulatory Action, February 20, 2007
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1240.3522 - Review and Evaluation of Drug Experience Reports, February 20, 2007
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1240.3530 - Procedures for Processing Drug Experience Reports, February 20, 2007
CVM Guidance
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Guidance for Industry 117: Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) - VICH GL24 - DRAFT GUIDANCE, May 2, 2006 | html | | pdf | | FR Notice |
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Guidance for Industry 142: Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) - VICH GL29 - Draft Guidance, December 12, 2001 | doc | pdf |
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Guidance for Industry 143: Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms - VICH GL30 - Draft Guidance, June 21, 2007 | html | | pdf | | FR Notice |
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Guidance for Industry 182: Pharmacovigilance of veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports - VICH GL42 - Draft Guidance, May 2, 2006 | html | | pdf | | FR Notice |
Journal Articles
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Hampshire VA, Evaluation of efficacy of heartworm preventative products at the FDA. Veterinary Parasitology, 2005 Oct 24; 133(2-3):191-195.
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Hampshire VA, Doddy FM, Post LO, et al., Adverse drug event reports at the United States Food and Drug Administration Center for Veterinary Medicine. J Am Vet Med Assoc., 2004 Aug 15; 225(4):533-536.
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Moskal TJ, Minimizing the risk factors associated with veterinary NSAIDS. J Am Vet Med Assoc., 2004 Apr 15; 224(8):1231-1232.
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Hampshire VA, Emerging issues regarding informed consent. J Am Vet Med Assoc., 2004 Jan 15; 224(2):177.
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Bataller N, Keller WC., Monitoring adverse reactions to veterinary drugs. Pharmacovigilance. Vet Clin North Am Food Anim Pract. 1999 Mar;15(1):13-30, vii-viii. Review.
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Keller WC, Bataller N, Oeller DS, Processing and evaluation of adverse drug experience reports at the Food and Drug Administration Center for Veterinary Medicine, J Am Vet Med Assoc. 1998 Jul 15;213(2):208-11.
Other FDA Adverse Experience Reports
Web Page Updated by jmo - June 21, 2007, 9:18 AM ET
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