Animal & Veterinary

Veterinary Adverse Event Reporting for Manufacturers


Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360b(l)) requires applicants to establish and maintain records and make such reports of data relating to experience with uses and other data or information received or obtained by the applicant with respect to such drug as required by regulation or order. Section 514.80 (b) (21 CFR 514.80(b)) of FDA regulations requires applicants of approved new animal drug applications (NADAs) and approved abbreviated new animal drug applications (ANADAs) to report ADEs and product and manufacturing defects.This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA’s Center for Veterinary Medicine (CVM) obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product/manufacturing problems.

How to Report an Adverse Drug Experience

Paper Reporting Forms:

CVM will continue to accept adverse drug event reports on paper if the applicant is unable or unwilling to submit these reports electronically.

After January 30, 2015 CVM will only accept the current version of Form FDA 1932 (OMB No. 0910-0645).

Electronic Reporting:

CVM now accepts electronic submission of adverse event information for veterinary drugs.  Electronic submission of adverse event information will be possible through the Electronic Submissions System (ESS) and the Rational Questionnaire (RQ) in the Safety Reporting Portal (SRP), a joint FDA-National Institutes of Health initiative.

The ESS integrates with the FDA Electronic Submissions Gateway (FDA ESG) to allow adverse drug experience reports, either individually or in batches, to be transmitted directly from industry to CVM via gateway-to-gateway submission.

The Rational Questionnaire in the SRP provides another option for animal drug manufacturers to submit adverse event reports electronically to CVM.  The Rational Questionnaire is a web-based questionnaire that displays a series of questions to be answered by the person submitting the report.  These questions are intended to ensure proper collection of the information that is needed by FDA to appropriately evaluate the reported incident. Since the SRP only supports transmission of individual reports via the Rational Questionnaire, companies wanting to send batches of multiple reports might prefer the gateway-to-gateway method.

2013 Revision: In June 2013, CVM implemented an updated version of its electronic submissions systems for adverse event reporting (hereinafter referred to as “the June 2013 revision”). SRP users are already using the June 2013 revision. Since June 2013, CVM has been accepting ESS submissions using either the June 2013 revision or the May 2010 implementation to allow applicants time to transition to the June 2013 revision by upgrading and validating their databases and systems.
This transition period will end December 9, 2015, after which time CVM will only accept ESS submissions using the June 2013 revision.

Instruction and documentation for both versions of ESS (June 2013 revision and May 2010 implementation) are provided under the “Supporting Documents” header at the bottom of this page.

Three-day Field Alert Reports:

Three-day NADA/ANADA Field Alert Reports must be submitted directly to the appropriate FDA District Field Office or local FDA resident post. The information initially may be provided by telephone or other telecommunication means, with prompt written follow up using and the paper Form FDA 1932. (See 21 CFR 514.80(b)(1)).

Currently, FDA does not have the electronic capability to share with the FDA District Office or local resident post electronic reports submitted through gateway-to gateway electronic submission or the SRP.  If the MAH elects to submit a three-day NADA/ANADA field alert report directly to FDA’s CVM, the MAH may use the gateway-to-gateway submission, the SRP, or the paper form.  However, if the MAH chooses to submit this report directly to FDA’s CVM, this does not alleviate the MAH’s responsibility to submit this report (via telephone or other telecommunication means, and paper form) to the FDA District Field Office or local FDA resident post (see 21 CFR 514.80(b)(1)).

If submitting a three-day NADA/ANADA field alert report using the paper form, we prefer that the revised Form FDA 1932 (OMB No. 0910-0645) be used. 

How to report electronically:

Safety Reporting Portal:  The SRP has separate procedures for creating a user account that do not require registration with the FDA ESG.  Users simply follow the directions to provide contact information and create a password.


Refer to the document Instructions for Submitting Mandatory Electronic Adverse Event Reports to FDA CVM found below.

General Instructions

Supporting Documents- June 2013 Revision

Supporting Documents - May 2010 Implementation

Contact FDA

CVM ADE Support

Page Last Updated: 08/21/2015
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