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Faster Approval for Emergency Drugs and Medical Devices

This act allows data collected during 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 improving access to vital therapies and diagnostic tools.
Key points
Emergency use data (e.g., vaccines, tests) can now support permanent product approval.
Speeds up market entry for drugs and devices proven effective in crisis situations.
Ensures safety and efficacy standards remain, but the evaluation process is more flexible.
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Expired
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Additional Information
Print number: 117_HR_4511
Sponsor: Rep. Burgess, Michael C. [R-TX-26]
Process start date: 2021-07-19
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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

FACTS Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_HR_4511.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2021-07-19.

What are the main provisions?

Key points include:

  • Emergency use data (e.g., vaccines, tests) can now support permanent product approval.
  • Speeds up market entry for drugs and devices proven effective in crisis situations.
  • Ensures safety and efficacy standards remain, but the evaluation process is more flexible.
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 Rep. Burgess, Michael C. [R-TX-26].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-28.

CATEGORIES

Health