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Drug Safety: Faster Label Updates for Patient Protection

New rules aim to speed up the process of updating safety information on generic drug labels. This will allow manufacturers to quickly add new warnings or instructions, enhancing patient safety and ensuring access to the most current drug data.
Key points
Generic drug manufacturers can update labels faster with new safety information.
Label changes can be implemented even before official approval by authorities.
Detailed rules for these changes and their standardization with other drugs will be established within 18 months.
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Additional Information
Print number: 117_HR_9011
Sponsor: Rep. McEachin, A. Donald [D-VA-4]
Process start date: 2022-09-28
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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

Updated Drug Labeling for Patient Safety Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_HR_9011.

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 2022-09-28.

What are the main provisions?

Key points include:

  • Generic drug manufacturers can update labels faster with new safety information.
  • Label changes can be implemented even before official approval by authorities.
  • Detailed rules for these changes and their standardization with other drugs will be established within 18 months.
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. McEachin, A. Donald [D-VA-4].

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