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GUIDANCE DOCUMENT

Forms FDA 3542a and FDA 3542: Questions and Answers June 2026

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2026-D-2698
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled “Forms FDA 3542a and FDA 3542: Questions and Answers.” This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542 and to assist applicants in preparing and submitting these forms to FDA.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2026-D-2698.

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