# New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/new-clinical-investigation-exclusivity-3-year-exclusivity-for-drug-products-questions-and-answers/19bf8380-085c-46d8-a480-d28b1c37d3de

> FDA guidance document: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers. Issue date: March 03, 2026. Get complete insights and analysis.

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## Details

- Title: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2026-03-03
- Last Changed: 2026-03-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-4388">FDA-2024-D-4388</a>

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