FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: NONCLINICAL TESTING TERMINOLOGY

WASHINGTON, Sept. 22 -- Food and Drug Administration has issued a proposed rule called: Nonclinical Testing Terminology.

The proposed rule was published in the Federal Register on Sept. 22 by Robert F. Kennedy, Secretary, Department of Health and Human Services.

Summary: The Food and Drug Administration (FDA, Agency, or we) is proposing to substitute references to "animal" tests or studies with "nonclinical" tests or studies, add a definition of the terms "nonclinical test" and "nonclinical study, " and make other comparable or conforming amendments in certain safety and reporting sections of its regulations. The proposed rule would also substitute "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. These propos...