FDA GUIDANCE · DRAFTJune 15, 2026

Forms FDA 3542a and FDA 3542: Questions and Answers

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Draft

Topic

Drug Competition Action Plan, Generic Drugs

Issue date

June 15, 2026

This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.

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