Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Translation of GLP Study Reports: Questions and Answers."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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2023-D-4719] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Translation of GLP Study Reports: Questions and Answers.”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 ( printed page 81420) 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. DATES: Submit either electronic or written comments on the draft guidance by February 20, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: E…
Citation: 88 FR 81419
