Records and Reports Concerning Experience With Approved New Animal Drugs

The Food and Drug Administration (FDA) is amending its requirements for records and reports of adverse experiences and other information for approved new animal drugs. This interim final rule more clearly defines the kinds of information to be maintained and submitted by new animal drug applicants for a new animal drug application (NADA) or an abbreviated new animal drug application (ANADA). 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 recordkeeping and reporting requirements.