FDA opens access to adverse event data

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The Food and Drug Administration is offering data about adverse events in animals that can be useful for researchers and software developers.

Published in machine-readable format, those data are from reports on drugs and devices since Jan. 1, 1987, according to an agency announcement. They had been available before only through Freedom of Information Act requests.

They involve products that are approved, unapproved, and compounded.

"The FDA anticipates that this increased transparency will help to spur veterinarians, pet owners and other animal care providers, and members of the public to enhance reporting to the FDA or product manufacturers when animals experience adverse events after receiving an animal drug or using a device," an agency announcement states. "Complete and detailed reports are immensely helpful to the agency when identifying safety signals and determining which products may require additional investigation."

The agency is providing the data, which researchers and statisticians use to access large public health datasets provided by the FDA, the announcement states. Though the agency has some tools to explore adverse event data, at press time, those tools were available only for use with reports from human medicine.

FDA officials plan to update the data on animal-use drugs and devices each quarter.