For approval of a new animal drug, section 512 of the Federal Food, Drug, and Cosmetic Act requires that adequate tests show whether or not the drug is safe and that there is substantial evidence of effectiveness. Substantial evidence is defined in section 512 as one or more adequate and well controlled studies. Essential characteristics of adequate and well-controlled studies intended to demonstrate effectiveness are described in 21 CFR 514.117. To demonstrate that a study supporting an effectiveness claim is adequate and well-controlled, sponsors usually submit extensive documentation of study planning, protocol, conduct, and data handling to FDA, and all study documentation is made available at the study sites. Similarly, to demonstrate that a study intended to support a finding that a new animal drug is safe is adequately designed and conducted, sponsors usually submit extensive documentation of study planning, protocol, conduct, and data handling to FDA, and all study documentation is made available at the study sites.

From a scientific standpoint, however, FDA recognizes that the extent of documentation necessary depends on the particular study, the types of data involved, and the other evidence available to support the claim. Therefore, FDA is able to accept different levels of documentation of data quality, as long as the adequacy of the scientific evidence can be assured. This guidance discusses the factors that influence the extent of documentation needed.

Questions?