Clinical Investigation in Animals

Abstract

The Code of Federal Regulations Part 511 addresses the requirements for new animal drugs for investigational use. In 1977, the Food and Drug Administration proposed new rules for the conduct of clinical trials. Although these are only proposed regulations, the FDA uses them as guidelines when conducting audits of clinical investigators. These proposed Good Clinical Practice Regulations have resulted in an improvement in the manner animal clinical studies are now conducted. We feel the results have been positive for all concerned, the public, sponsor and the Food and Drug Administration.