HHS FDA Issues Draft Guidance on Patent Submission Forms for Drug Applications
June 15, 2026
June 15, 2026
WASHINGTON, June 15 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has released draft guidance intended to help pharmaceutical companies prepare and submit patent information using Forms FDA 3542a and FDA 3542, seeking public comment before finalizing the document. The guidance addresses common questions about the forms used by applicants and holders of New Drug Applications when submitting patent information related to prescription drugs.
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