Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Translation of GLP Study Reports: Questions and Answers." This guidance provides information to sponsors and nonclinical laboratories regarding the translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations. GLP studies are nonclinical safety studies that include, but are not limited to nonclinical toxicology studies, safety pharmacology studies, and device safety studies. When study reports of GLP studies are translated from the original language into English, adequate documentation is critical to ensure accurate and complete study data are submitted to FDA. This question- and-answer document is intended to clarify FDA's recommendations concerning the translation of GLP study reports from a non-English language into English for nonclinical studies conducted in compliance with GLP regulations.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.