FDA amends rules on adverse drug experience records

Published on April 15, 2002
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The Food and Drug Administration Center for Veterinary Medicine is amending the requirements for records, reports of adverse experiences, and other information for approved new animal drugs.

According to the Feb. 4 Federal Register, this interim final rule more clearly defines the kinds of information to be maintained and submitted for a new animal drug application or an abbreviated new animal drug application.

In addition, the interim final rule revises the timing and content of certain reports to enhance their usefulness. The regulation will provide for protection of public and animal health and reduce unnecessary record keeping and reporting requirements. This interim rule is effective Aug. 5, 2002. Comments on new information were to be submitted to the FDA-CVM by April 5.

The AVMA filed specific comments regarding definitions and reporting requirements found in the interim rule. In addition, the AVMA communicated key points it believes should be included in an effective adverse event reporting system.

The key points included encouraging the FDA to factor adverse events of non-approved animal products into its regulatory strategy for these products, including animal supplements/nutraceuticals, chemicals, botanicals, herbals, and devices.

The AVMA supported improved analysis of submitted reports and transmittal of medically relevant information back to veterinarians. The sharing of such information is in the interest of animal and public health and serves as an incentive to veterinarians to make additional appropriate adverse event reports.

The interim final rule may be found at www.fda.gov/OHRMS/DOCKETS/98fr/020402a.htm. Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855; (301) 827-3800.

For more information, contact Dr. William C. Keller, Center for Veterinary Medicine (HFV-210), FDA, 7500 Standish Place, Rockville, MD 20855; (301) 827-6641; wkelleratcvm [dot] fda [dot] gov.