FDA Logo links to FDA home page HHS Logo links to Department of Health and Human Services website U.S. Food and Drug Administration Center for Veterinary Medicine link to the Minor Uses and Minor Species page link to the Antimicrobial Resistance page link to the Biotechnology page link to the Aquaculture page link to the Food Safety page link to the BSE page link to the Guidance Documents page link to the Green Book page link to the Freedom of Information page
Center for Veterinary Medicine
Spacer
Spacer
Spacer

Search

Powered by Google


" "

Table of Contents

Spacer Spacer
Additional Veterinary ADE Information

CVM Update

Federal Register Notices

  • 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

  • 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

  • 1240.3510 - Drug Experience Reporting Requirements, February 20, 2007

  • 1240.3512 - Additional Sources of Adverse Reaction and Injury Reports, February 20, 2007

  • 1240.3514 - Drug Experience Reporting by Veterinarians, February 20, 2007

  • 1240.3520 - Adverse Reactions as a Basis for Regulatory Action, February 20, 2007

  • 1240.3522 - Review and Evaluation of Drug Experience Reports, February 20, 2007

  • 1240.3530 - Procedures for Processing Drug Experience Reports, February 20, 2007

CVM Guidance

  • 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117: Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) - VICH GL24 - DRAFT GUIDANCE, May 2, 2006 | html | | pdf | | FR Notice |

  • 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Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) - VICH GL29 - Draft Guidance, December 12, 2001 | doc | pdf |

  • Guidance for Industry 143: Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms - VICH GL30 - Draft Guidance, June 21, 2007   | html | | pdf | | FR Notice |

  • 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of veterinary Medicinal Products:  Data Elements for Submission of Adverse Event Reports - VICH GL42 - Draft Guidance, May 2, 2006 | html | | pdf | | FR Notice |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

Other FDA Adverse Experience Reports


 


Web Page Updated by jmo - June 21, 2007, 9:18 AM ET




Spacer
Spacer
horizonal rule