New Animal Drugs for Investigational Use and New Animal Drug Applications; Reopening of Comment Period

Zusammenfassung

The Food and Drug Administration (FDA) is reopening to June 9, 1997 the comment period for the advance notice of proposed rulemaking (ANPRM) for investigational use new animal drug (INAD) regulations and the new animal drug applications (NADA) regulations that published in the Federal Register of November 21, 1996. The comment period is being reopened for the sole purpose of inviting interested persons to submit comments that will give FDA guidance in developing proposed regulations defining ``good study practices.'' Elsewhere in this issue of the Federal Register, FDA is publishing a related document, a proposed rule further defining adequate and well-controlled studies. The definition of adequate and well-controlled studies requires that such a study, when conducted in the target animal, be conducted in compliance with good study practices.