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Faster Generic Drug Approvals: Increased Transparency for Manufacturers.

This law mandates the FDA to increase transparency during the generic drug approval process. It requires the agency to quickly inform generic manufacturers if their inactive ingredients match the brand-name drug's formulation. This change aims to reduce delays, speed up market entry for cheaper generic alternatives, and potentially lower prescription costs for consumers.
Key points
The FDA must disclose to generic drug applicants whether their inactive ingredients are qualitatively and quantitatively the same as the original brand-name drug.
If differences exist, the FDA must specify which ingredients are different and the extent of the quantitative deviation, allowing for faster corrections.
The FDA must issue guidance within one year detailing how these formulation comparisons will be made, ensuring consistent standards.
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Additional Information
Print number: 118_S_775
Sponsor: Sen. Hassan, Margaret Wood [D-NH]
Process start date: 2023-03-14
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OFFICIAL LEGAL TITLE

Increasing Transparency in Generic Drug Applications Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_S_775.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-03-14.

What are the main provisions?

Key points include:

  • The FDA must disclose to generic drug applicants whether their inactive ingredients are qualitatively and quantitatively the same as the original brand-name drug.
  • If differences exist, the FDA must specify which ingredients are different and the extent of the quantitative deviation, allowing for faster corrections.
  • The FDA must issue guidance within one year detailing how these formulation comparisons will be made, ensuring consistent standards.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Hassan, Margaret Wood [D-NH].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-30.

CATEGORIES

Health