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Faster Drug Approval: Relying on Foreign Safety and Efficacy Data.

This bill aims to speed up the availability of new prescription drugs for US citizens by allowing manufacturers to use clinical and safety data from investigations conducted in specific foreign countries where the drug is already approved. This mechanism could provide patients with quicker access to therapies already vetted and marketed in trusted jurisdictions. The FDA review timeline for these applications is significantly shortened to 90 days.
Key points
Accelerated Review Timeline: The FDA must decide on applications relying on foreign data within 90 days, significantly shortening the standard approval process.
Acceptance of Foreign Studies: Manufacturers can rely on safety and effectiveness data from studies conducted in trusted partner countries, including the UK.
New Expert Committee: A dedicated Foreign Drug Review Advisory Committee will be established to evaluate these applications, ensuring safety standards are maintained.
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Additional Information
Print number: 118_S_1132
Sponsor: Sen. Braun, Mike [R-IN]
Process start date: 2023-03-30
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Summarized by: gemini-2.5-flash-preview-09-2025
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

ADAPT 2.0 Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_S_1132.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-03-30.

What are the main provisions?

Key points include:

  • Accelerated Review Timeline: The FDA must decide on applications relying on foreign data within 90 days, significantly shortening the standard approval process.
  • Acceptance of Foreign Studies: Manufacturers can rely on safety and effectiveness data from studies conducted in trusted partner countries, including the UK.
  • New Expert Committee: A dedicated Foreign Drug Review Advisory Committee will be established to evaluate these applications, ensuring safety standards are maintained.
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. Braun, Mike [R-IN].

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 2025-12-26.

CATEGORIES

Health