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Faster Approval for Emergency Drugs and Medical Devices.

New rules allow data from emergencies (e.g., pandemics) to be used for faster approval of drugs, biological products, and medical devices. This means products proven effective in a crisis can reach the market for general use more quickly, potentially speeding up access to vital therapies and diagnostic tools for citizens.
Key points
Data gathered during emergencies (e.g., emergency use authorizations) can support applications for permanent approval of drugs and medical devices.
This facilitates quicker market entry for products already demonstrated as effective and safe in crisis situations.
It does not alter safety standards or approval requirements, only allows the use of existing, reliable data.
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Expired
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Additional Information
Print number: 117_S_1508
Sponsor: Sen. Marshall, Roger [R-KS]
Process start date: 2021-04-29
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_1508.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2021-04-29.

What are the main provisions?

Key points include:

  • Data gathered during emergencies (e.g., emergency use authorizations) can support applications for permanent approval of drugs and medical devices.
  • This facilitates quicker market entry for products already demonstrated as effective and safe in crisis situations.
  • It does not alter safety standards or approval requirements, only allows the use of existing, reliable data.
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. Marshall, Roger [R-KS].

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 2025-12-29.

CATEGORIES

Health