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Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
Comment period closed: closed 64 days ago (Aug 14, 2026).
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.
- Document type
- Notice
- Federal Register document number
- 2026-11966
- Published
- Jun 15, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-D-2698
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by August 14, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Other FDA topics
Source: Federal Register API, document 2026-11966. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.