CVM Update

• FDA Amends Rules on ADE Records and Reports – February 5, 2002

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, November 23, 1993

• 1240.3512 - Additional Sources of Adverse Reaction and Injury Reports, November 23, 1993

• 1240.3514 - Drug Experience Reporting by Veterinarians, May 27, 1997

• 1240.3520 - Adverse Reactions as a Basis for Regulatory Action, November 23, 1993

• 1240.3522 - Review and Evaluation of Drug Experience Reports, November 23, 1993

• 1240.3530 - Procedures for Processing Drug Experience Reports, November 23, 1993

CVM Guidance

• Guidance for Industry 117: Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) - VICH GL24 - DRAFT GUIDANCE, Decenber 12, 2000
  | doc | | pdf |

• 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Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) - VICH GL29 - Draft Guidance, December 12, 2001 | doc | pdf |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Guidance for Industry #143: Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms - VICH GL30 - Draft Guidance, February 1, 2002
  | doc | | pdf |

Journal Articles

• 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.

• 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

• Blood Products

• Devices

• Dietary Supplements/Special Nutritionals

• Human Drugs

• Vaccines

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