The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.
US Federal Register - FDA Guidance Notices · June 15, 2026
Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry
Original title: Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
FDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.