Animal & Veterinary
FDA Publishes Substantial Evidence Final Rule
July 29, 1999
FDA's final rule amending the new animal drug regulations to further define the term "substantial evidence'' published in the July 28, 1999, Federal Register.The purpose of this final rule is to encourage the submission of new animal drug applications (NADAs) and supplemental NADAs for single ingredient and combination new animal drugs.The final rule also encourages dose range labeling.This final rule implements, in part, the Animal Drug Availability Act of 1996 (ADAA), which amended the Federal Food, Drug, and Cosmetic Act.The purpose of the ADAA is to facilitate the approval and marketing of NADAs and medicated feeds.
Before FDA can approve a new animal drug, FDA must find, among other things, that there is substantial evidence that the new animal drug is effective for its intended uses under the conditions of use prescribed, recommended, or suggested in the proposed labeling.The changes made to the definition of "substantial evidence'' by the ADAA and by the further definition of that term in this final rule give FDA greater flexibility to make case-specific scientific determinations regarding the number and types of adequate and well-controlled studies that will provide, in an efficient manner, substantial evidence that a new animal drug is effective.
A copy of this final rule may be obtained from our Home Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.
Further information about this final rule may be obtained from the July 28, 1999, Federal Register and from Dr. Herman M. Schoenemann, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0220.