This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in the development of drugs to ensure that translation of a study report into English from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Electronic or written comments should be submitted on the draft guidance by February 20, 2024
