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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2023-D-4719
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This FDA guidance 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) submitted to FDA for review.