S 1302
Increasing Transparency in Generic Drug Applications Act
Jurisdiction
US Congress
Session
119th Congress (2025-2026)
Last updated at
Jun 14, 2026, 8:37 AM
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Sign in to take action- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
This bill, the Increasing Transparency in Generic Drug Applications Act, aims to increase transparency in the process of generic drug approvals. Specifically, it requires the Food and Drug Administration (FDA) to inform a drug applicant if a generic drug is substantially similar to the brand-name drug it’s trying to replicate, detailing any differences in ingredients and amounts. The FDA will also issue guidance on how it determines this similarity, allowing for public comment before finalizing the guidance. This legislation seeks to ensure greater clarity and consistency in generic drug approvals.
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