US FDA Releases Draft Guidance on Translation for Good Laboratory Practice Study Reports

Us Fda Released Draft Guidance On Good Laboratory Practice Study Reports Translation
This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in the development of drugs to ensure that translation of a study report into English from a study conducted in compliance with GLP regulations, is clear, accurate, complete, and follow written processes and procedure.
The guidance is written in a Question-and-Answer format to provide answers in line with FDA’s recommendation on the topic.
Electronic or written comments should be submitted on the draft guidance by February 20, 2024
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