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The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
The F.D.A reviewed over 3,600 adverse-effects cases that were submitted to them and to the makers of Librela, before reporting their findings. Although it should be noted that the report does not ...
Human adverse reactions (a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine) Unintended transmission of an infectious agent through a veterinary medicinal product; All other adverse events must be reported in a Periodic Safety Update Report.
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with ...
Maropitant (INN; [3] brand name: Cerenia, used as maropitant citrate , is a neurokinin-1 (NK 1) receptor antagonist developed by Zoetis specifically for the treatment of motion sickness and vomiting in dogs. It was approved by the FDA in 2007, for use in dogs [4] [5] and in 2012, for cats. [6]
Zoetis Inc. (/zō-EH-tis/ [4]) is an American drug company, the world's largest producer of medicine and vaccinations for pets and livestock. [ 5 ] [ 4 ] [ 6 ] The company was a subsidiary of Pfizer , [ 7 ] the world's largest drug maker , but with Pfizer's spinoff of its 83% interest in the firm it is now a completely independent company.
The FDA provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
A vaccine-associated sarcoma (VAS) or feline injection-site sarcoma (FISS) is a type of malignant tumor found in cats (and, often, dogs and ferrets) which has been linked to certain vaccines.