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# Draft Guide on Generic 180-day Exclusivity
- URL: https://www.fdaweb.com/draft-guide-on-generic-180-day-exclusivity/
- Published: 2017-01-12T12:00:00.000Z
- Updated: 2026-09-14T21:59:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137710

FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536725.pdf?ref=fdaweb.com) on “180-Day Exclusivity: Questions and Answers” that addresses questions that have been raised about Food, Drug, and Cosmetic Act provisions related to generic drug exclusivity. The agency believes such a guidance “would enhance transparency and facilitate the development, approval, and timely marketing of generic drug products.” Many policy decisions have been made within the context of application-specific decisions, or under citizen petition responses, and the guidance would serve as a repository for the regulatory action explanations.