S. 775 · 118th Congress
Increasing Transparency in Generic Drug Applications Act
- Stage
- In committee
- Sponsor
- Maggie Hassan
- Introduced
- 2023-03-14
- Latest action
- 2023-03-14 · Introduced in Senate
Summary
Increasing Transparency in Generic Drug Applications Act
This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.