FDA Asks for Input on Reporting Pet Drug Side Effects
Published Date: 2/20/2026
Notice
Summary
The FDA wants your thoughts on how it collects reports about problems with new animal drugs and manufacturing issues. This affects drug makers, vets, and pet owners who help spot side effects in animals. Comments are open until April 21, 2026, so jump in now to help shape safer animal medicines without adding extra costs or delays.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Animal-drug makers: large reporting burden
If you are an applicant or other maker of approved new animal drugs, you must keep records and submit postmarketing adverse event and manufacturing-defect reports under section 512(l) of the FD&C Act and 21 CFR 514.80. FDA lists required forms (FDA Form 1932 and 2301), requires electronic submission of postmarketing safety reports (with limited temporary waivers), and estimates total annual reporting of about 139,561 responses and 194,349.5 hours and total annual recordkeeping of about 124,443 records and 1,742,132 hours (OMB Control Number 0910-0284).
Vets and pet owners: voluntary adverse-event reports
Veterinarians and pet owners can voluntarily report animal adverse events to FDA using FDA Form 1932a; FDA estimates about 217 voluntary public reports per year totaling about 217 hours. These voluntary reports help FDA monitor safety of new animal drugs.
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