FORM FDA 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness, or Product Defect Report 2025

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For unapproved drugs and devices, submit FORM FDA 1932a, Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report. You can use this form to report adverse events for any animal drug (FDA-approved or unapproved) or animal device.
FDA Form 3500 should be used by healthcare professionals and FDA Form 3500B should be used by patients or consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care.
Animal foods and FDA-approved products, such as animal medications and devices report the adverse event to the FDA online or by calling 1-888-FDA-VETS (1-888-332-8387).
There are several ways to report: to your vet or retailer: Its a good idea to let your vet know if your animal has experienced a reaction. to the Marketing Authorisation Holder (MAH): Contact details are always given on the product packaging and leaflet.
ADRs can be also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to 5:30 pm. [3] The mobile Android application for ADR reporting has also been made available to the public.

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Anyone can report a reaction to a veterinary medicine that affects a person, animal or the environment. You can also report if an animal medicine has not worked. It is particularly important for vets to report events and provide as much clinical detail as possible.

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