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USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports

On 21 November,2023 the USFDA issued updated guidance on "Translation of Good Laboratory Practice Study Reports: Questions and Answers" that provides information to sponsors and nonclinical laboratories regarding the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations (21 CFR part 58).

There are times when studies conducted in compliance with GLP regulations are conducted by testing facilities outside of the United States. When the GLP study report is generated in a language other than English, FDA often requires the study report to be translated into English.

During the translation of a study report into English, it must be clear, accurate, complete, truthful, and follow written processes and procedures. As part of the sponsor's responsibility, the translated report should be a true representation of the original GLP study report.

To ensure accurate and complete study data are submitted to the FDA when GLP study reports are translated from their original language into English, adequate documentation is crucial.

The recommendations for translating GLP study reports described in this guidance will provide stakeholders with an understanding of the documentation necessary to ensure study reports translated from the original language into English are accurate, complete, and truthful.

Check out this guidance by clicking this LINK to know more about the questions and answers regarding the Translation of Good Laboratory Practice.

Also earlier today (24 November, 2023) there was guidance released on "COVID-19: Developing Drugs and Biological Products for Treatment or Prevention" to assist sponsors in the clinical development of drugs and biological products for the treatment or prevention of COVID-19. FDA's current recommendation for phase 2 and phase 3 trials is presented in this guidance, which focuses on trial population, trial design, efficacy endpoints, safety considerations, and statistical considerations.


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