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Increasing Transparency in Generic Drug Applications Act

In committee: it can still change before the session ends.

US S 1302 · Senate Bill · 119th Congress

Draft a letter
Stage
In committee
Started in
Senate
Sponsors
7
Latest action
Apr 3, 2025

What it does

The Increasing Transparency in Generic Drug Applications Act would amend the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to disclose, upon request, whether a proposed generic drug contains the same inactive ingredients in the same concentrations as the brand-name drug it seeks to copy, and to identify any discrepancies if they exist. The bill applies to manufacturers submitting or planning to submit abbreviated new drug applications (ANDAs) for drugs requiring specific inactive ingredient profiles, and mandates that the Secretary issue guidance within one year of enactment on how to determine qualitative and quantitative sameness, including a…

No official summary is available here. This one was written by AI from the bill’s text.

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Where it stands

  1. Introduced (Done)

    Apr 3, 2025

  2. Committee (Current step)

    In committee · Apr 3, 2025

  3. Floor (Not started)

  4. Law (Not started)

What moved

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Who is involved

Sponsors

The lawmakers who put their names on it, lead sponsors first.

Where it goes next

While a bill can still move, the questions are about people and money.

Work with this bill

Increasing Transparency in Generic Drug Applications Act | 52