Adequate and Well-Controlled Studies for Investigational Use and Approval of New Animal Drugs

Samenvatting

The Food and Drug Administration (FDA), as directed by the Animal Drug Availability Act of 1996 (ADAA), is publishing a proposed regulation to further define the term ``adequate and well-controlled'' to require that field investigations be designed and conducted in a scientifically sound manner. Elsewhere in this issue of the Federal Register, FDA is reopening docket number 96N-0411 to receive comments regarding a concept, ``good study practices,'' that is related to the definition of adequate and well-controlled studies.