FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: FORMS FDA 3542A AND FDA 3542: QUESTIONS AND ANSWERS; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, June 15 -- Food and Drug Administration has issued a notice called: Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on June 15 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.

For more information, contact Rachel Erdman, Office of ...