Description
The purpose of this guidance is to assist applicants (referred to as Marketing Authorization Holder (MAH) in this guidance) and nonapplicants with filling out Form FDA 1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” As required by Food and Drug Administration (FDA) regulations at 21 CFR 514.80, an applicant must report adverse drug experiences (ADEs) and product/manufacturing defects on Form FDA 1932. Firms named on the label as a manufacturer, packer, or distributor may also use this form.
Scope & Applicability
Product Classes
4The guidance applies to residual solvents in these products
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
Veterinary Medicinal Product used in planned studies or spontaneous reports; Veterinary Medicinal Product involved in an adverse event
Veterinary products not FDA-approved but marketed in the U.S.; Category of animal drugs not formally approved but subject to reporting.
Stakeholders
10Entity responsible for managing the submission of PBRERs
The individual in charge of the AER or PPR message.
The organisation that is submitting the ICH ICSR.
Entity involved in investigational drug supply chain
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Role of the person who may have administered the VMP
Marketing Authorization Holder responsible for safety reporting; Marketing Authorization Holder responsible for providing exposure data; Marketing Authorization Holder responsible for signal evaluation and reporting.; Marketing Authorization Holder responsible for presenting efficacy information
Person other than the applicant whose name appears on the label
The person or organization providing the most pertinent information related to an AER.
Professional providing assessment of animal health status prior to VMP; provides assessment regarding the association between the VMP and the AE
Regulatory Context
Attributes
10Assessment of the animal's condition prior to exposure
AERs involving a VMP same as or similar to an FDA-regulated VMP occurring outside the US.
AERs involving an FDA-regulated VMP regardless of the country where the AE occurs.
relevant category for submission of the paper form
Criteria including death, life-threatening, hospitalization, disability, or congenital anomaly.; For serious AEs/ADRs, it is important to continue follow-up
Property of a device that may be changed via established protocols
This field request information regarding the date on which the animal was first treated with the VMP.
This is the frequency of administration of the VMP(s) involved in the AE.
This is the actual dose administered to the animal involved in the AE.; Field B.2.1.7.1 in the adverse event report
Describes whether the affected animal is intact or neutered
Identified Hazards
Hazards
1Defects in VMP that may lead to safety issues or LOEE
Related CFR Sections (2)
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR514.3§ 514.3 Definitions.
The definition and interpretation of terms contained in this section apply to those terms as used throughout subchapter E.Read full regulation →
See Also (8)
- CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's) (Status: Draft)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)
- CVM GFI #231 Distributor Labeling for New Animal Drugs (Status: Final)
- CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting (Status: Final)
- CVM GFI #240 Proprietary Names for New Animal Drugs (Status: Final)
- CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances (Status: Final)
- CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)