Rockville, Md. -- The U.S. Food and Drug Administration (FDA) is adding a new component to adverse drug experience reports, now requiring the frequency of reactions to be added.
Rockville, Md.
— The U.S. Food and Drug Administration (FDA) is adding a new component to adverse drug experience reports, now requiring the frequency of reactions to be added.
Previously FDA’s Center for Veterinary Medicine only included the signs associated with adverse reactions in the Cumulative ADE Summary Reports. Now, in response to increased interest from the public, the agency will list the number of times certain reactions were reported.
ADE reports are accessible through a database on FDA’s website, and offer veterinarians and animal owners information about possible reactions associated with active ingredients used in animal drugs. The main goal of the database, according to FDA is to identify reactions not detected during pre-market testing of FDA-approved animal drugs, and for monitoring the performance of unapproved drugs.
The agency will now list signs associated with adverse reactions from most to least frequent, says FDA.
From exam room tips to practice management insights, get trusted veterinary news delivered straight to your inbox—subscribe to dvm360.
FDA approves oral drug for broad canine protection against parasites
October 7th 2024Elanco's lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets (Credelio Quattro) provide a single monthly dose for protection against fleas, ticks, heartworms, roundworms, hookworms, and 3 species of tapeworm.
Read More