U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

2 Legal Framework Jennifer Gresock, Assistant Chief Counsel for Veterinary Medicine Office of the Commissioner Office of the General Counsel, Food and Drug Division Office of the Chief Counsel

3 The Federal Food, Drug, and Cosmetic Act The Center for Veterinary Medicine (CVM) has regulatory responsibility for ensuring the safety of marketed animal drug products Section 512 of the Act – New Animal Drug Applications (NADAs)

4 New Animal Drug Applications (NADAs) NADA for a new animal drug product is approved based on a showing that the product is safe and effective for its intended use

5 Establishing Safety Full reports of adequate tests by all methods reasonably applicable to show whether the drug is safe for use as suggested in the proposed labeling [21 CFR 514.1(a)(8)]

6 Labeling Labeling should indicate how to use the drug in a safe and effective manner Drug is misbranded unless its labeling bears adequate directions for use [Section 502(f) of the Act]

7 Post-Approval Monitoring CVM monitors drugs after approval to ensure continued safety and effectiveness Section 512(l): recordkeeping and reports of data relating to experience with uses of approved new animal drugs Adverse event reporting is a post- approval monitoring tool (21 CFR )

8 Adverse Drug Experiences, or ADEs Adverse drug experience: any adverse event associated with the use of a new animal drug, whether or not considered to be drug related, and whether or not the new animal drug was used in accordance with the approved labeling [21 CFR 514.3]

9 ADEs Serious adverse drug experience: adverse event that is fatal, or life threatening, or requires professional intervention, or causes an abortion, or stillbirth, or infertility, or congenital anomaly, or prolonged or permanent disability, or disfigurement [21 CFR 514.3]

10 ADEs Unexpected adverse drug experience: adverse event that is not listed in the current labeling for the new drug and includes any event that may be symptomatically and pathophysiologically related to an event listed on the labeling, but differs from the event because of greater severity or specificity [21 CFR 514.3]

11 ADE Reporting Sponsors must submit Form 1932 to FDA within 15 working days of receiving a report of a serious, unexpected adverse event from a consumer or veterinarian [21 CFR ]

12 ADE Reporting Other ADEs must be reported by the sponsor in Periodic Drug Experience Reports, which are submitted every 6 months for the first two years following product approval, and yearly thereafter [21 CFR ]

Ensuring Continued Safety FDA requested recall [21 CFR 7.45] Firm-initiated recall [21 CFR 7.46] Labeling and/or manufacturing changes Withdrawal under 512(e) of the Act - experience or scientific data - new evidence 13