To safeguard the health and welfare of animals, the FDA encourages veterinarians and animal owners to report adverse events associated with drugs or devices used in animals. We use this information to monitor the safety of products once they have reached the market.
What kind of problems do you want to report?
Adverse events:
- Researchers noted that animals given the substance exhibited side effects such as vomiting, diarrhea, colic, and seizures.
- Side effects can include needle stick injuries, rashes, or headaches when you come into contact with products that have been tested on animals.
- Product defects not only hurt consumers but can also result in painful lawsuits.
- Medication errors, most often due to miscommunication between a physician and pharmacist, can be avoided through close attention.
- An item that is not working as it should and the effects that it has on people’s lives.
Our APM will help in tracking all reporting related to drugs problems. Schedule a demonstrations call
What Drugs and Devices Can I Report to the FDA?
New animal drugs that have received approval from the US Food and Drug Administration, or FDA, use a six-digit New Animal Drug Application, or NADA, number. Generic animal drugs are assigned an Abbreviated New Animal Drug Application, or ANADA, number. On the packaging of many FDA-approved products you will find a statement that reads: “NADA XXX-XXX approved by the FDA.”
Indexed animal drugs are not approved by the FDA but can be legally marketed in limited quantities for specific purposes in certain minor species. The Minor Species Exception of the Federal Food, Drug and Cosmetic Act (FFDCA) allows these drugs to be marketed with a unique six-digit number on their labels (for example, MIF 9XX-XXX).
Unapproved animal drugs are every bit as important as human drugs, and they include such items as human drugs used in animals, compounded drugs, animal supplements, and other products.
Medical devices come in many shapes and sizes, such as thermometers, glucose meters, and bandage materials.
In the following paragraphs, you will learn how to report an event.
Many veterinary biologic products, including animal vaccines and flea and tick products, are not regulated by the FDA.
Animal Medicines and Devices – read the following
Veterinary vaccines promote animal health and wellness.
How Can I Report Adverse Animal Drug and Device Events?
You can report any side effects caused by a drug to the FDA in one of the following ways:
For an FDA-approved product or a product that’s indexed:
As an animal owner, you can report adverse drug events to the company responsible for the approved or Indexed drug product(s), which is required to submit reports of adverse drug events to the Food and Drug Administration (FDA). The drug company’s contact information can usually be found on the product’s labeling. When you call, tell them that you wish to report an adverse drug event and ask to speak to a technical services representative. The technical services representative will likely ask you a series of questions about the event and is required to send the information to the FDA’s Center for Veterinary Medicine (CVM). If you are an animal owner, the representative may also contact your veterinarian who treated your pet to obtain more information about the adverse drug event. The report will be assigned a unique case number by the company, which you can request.
To report directly to the FDA regarding an approved product, you can submit it from FDA 1932a.
For unapproved drugs and devices
For adverse events related to an animal drug or device, use FDA Form 1932a, “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report.” This form applies to both FDA-approved and unapproved animal drugs.
Use the following instructions to download the fillable 1932a form to your computer.
Please download the attached (as described below), print the copy supplied to you, fill in the information requested on the form, and return it to me.
- To get the 1932A form, right-click the above link.
- See the Save option on your browser’s menu bar. On most browsers, this is the Save Link As an option, but on other browsers, this may be Save Target as or Download Linked File.
Fill out the attached form and email it to us in order to get an estimate of our services. CVM1932a@fda.hhs.gov
If your report has been submitted by email, you will receive an automatic acknowledgment. Please keep a copy of this for your records. https://get.adobe.com/uk/reader/
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We will be happy to provide you with information regarding the regulations that must be adhered to when manufacturing animal drugs and a short demo of our cloud-based software, which allows you to monitor all aspects of the manufacturing process. Let’s connect now
Sangeetha brings 20 years of experience in Information Technology which includes Solution architecting, building micro services, research, and evaluation of business applications, integrating apps.