Devices

GLP Report Translation Q&A Guidance

FDA has published a draft guidance, Translation of GLP Study Reports: Questions and Answers, with information for sponsors and non-clinical laboratories about the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations. The document says GLP studies include nonclinical toxicology studies, safety pharmacology studies, and device safety studies received by different FDA Centers.

“When study reports of GLP studies are translated from their original language into English,” the guidance says, “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 study reports from a non-English language into English for studies conducted in compliance with GLP regulations. We expect that the recommendations for translating GLP study reports described in this guidance will increase our stakeholders’ understanding of the documentation needed to ensure study reports translated from the original language into English are clear, accurate, complete, and truthful.”

FDA says that while the draft does not address the reliable translation of other study reports submitted to support a marketing application, including studies that are not conducted in compliance with GLP regulations, the concepts described in it may be informative for the translation of such study reports.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome