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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA/CVM Final Rule Streamlines Adverse Event Reporting

FDA Veterinarian Newsletter May/June 2003 Volume XVIII, No 3

FDA/CVM has issued a final rule reducing FDA’s requirements for records and reports concerning experiences with approved new animal drugs. The final rule, published in the March 31, 2003, Federal Register, significantly reduces both reporting and record keeping requirements concerning experiences with New Animal Drug Applications (NADA) and Abbreviated NADAs (ANADA), as compared with current regulations, and incorporates many of the industry comments on earlier drafts.

This final rule clearly defines the kinds of information to be maintained and submitted by new animal drug applicants for an NADA or ANADA. It revises the timing and content of certain reports to enhance their usefulness. It provides for the protection of public and animal health, and reduces the record keeping and reporting requirements. Dr. Glenn Peterson, CVM Team Leader of the Marketed Products Information Team, noted that “applicants will now be able to petition FDA to change the frequency of reporting their yearly drug experience reports (DER’s), which should reduce their reporting to CVM.” This final rule is effective June 30, 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 ) or by contacting Dr. Glenn Peterson, Center for Veterinary Medicine (HFV-212), FDA, 7500 Standish Place, Rockville, MD 20855, 301-827-0224, gpeterso@cvm.fda.gov.