← FDA GUIDANCE
FDA GUIDANCE · DRAFTMarch 3, 2026
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: 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
Electronic Submissions, Drug Competition Action Plan, Generic Drugs
Issue date
March 3, 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This is a draft guidance — issued for comment and not for implementation.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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