FDA Final Rule Streamlines Adverse Event Reporting for New Animal Drugs
On April 1, the Food and Drug Administration (FDA) announced it had published a new regulation that improves the requirements for reporting adverse events associated with approved animal drugs. The reforms reduce certain reporting burdens while assuring collection of the information required to maintain high standards for protecting the health of animals as well as the public health, accordin
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On April 1, the Food and Drug Administration (FDA) announced it had published a new regulation that improves the requirements for reporting adverse events associated with approved animal drugs. The reforms reduce certain reporting burdens while assuring collection of the information required to maintain high standards for protecting the health of animals as well as the public health, according to a press release from the FDA.
The FDA invited interested parties to comment on the interim final rule that amended the regulations for records and reports on approved new animal drugs. The FDA drew upon those comments in shaping the final rule, which more clearly defines the kinds of information to be maintained and submitted by holders of approved new animal drug applications (ANADAs)
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