The U.S. Food and Drug Administration (FDA) has 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.
FDA invited interested parties to comment on the interim final rule that amended the regulations for records and reports on approved new animal drugs. 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).
In addition, the final rule revises the timing and content of certain reports to make them more useful to FDA's work to promote and protect animal and human health. For example, serious (fatal or life threatening) product defects will be reported in a separate report every three days instead of being combined with nonserious reports every 15 days. It will also reduce unnecessary recordkeeping and reporting requirements. Under the rule, reporting on adverse events will be streamlined, thereby reducing the amount of time and paperwork needed to provide useful baseline data.
Publication of the final rule demonstrates FDA's commitment to efficient regulation, based on sound science, for animal as well as human products. This rule is effective June 30, 2003. The interim final rule, which was published on February 4, 2002 (67 FR 5046), is withdrawn as of March 31, 2003.
Additional information about the final rule may be found in the March 31, 2003, Federal Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/03-7475.html).