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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability

Notice πŸ’¬ Comment by Aug 14 (16d left)
Health and Human Services Department, Food and Drug Administration
Notice
June 15, 2026
2026-11966
August 14, 2026 (16 days left)

πŸ“„ Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.
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