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FDA – Translation of Good Laboratory Practice Study Reports: Questions and Answers

The Food and Drug Administration (FDA) have released a new guidance document. This draft guidance is not for implementation, it has been distributed for comment purposes only.

The guidance provides information for sponsors and nonclinical laboratories regarding the language translation of study reports for studies conducted in compliance with good laboratory practice regulations (21 CFR part 58) submitted to FDA for review.

Find out more here.