Forms FDA 3542a and FDA 3542: Questions and Answers

Issue Date: June 15, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Drug Competition Action Plan, Generic Drugs
Status: Draft

Forms FDA 3542a and FDA 3542: Questions and Answers

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled “Forms FDA 3542a and FDA 3542: Questions and Answers.” This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542 and to assist applicants in preparing and submitting these forms to FDA.

Download the Guidance Document