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Extension of Rules for Approving Certain Drugs Until 2027

This act extends a provision concerning the approval of drugs containing single enantiomers until 2027. The change affects the regulatory process for bringing specific types of drugs to market.
Key points
The provision regarding the approval of drugs with single enantiomers is extended until October 1, 2027.
Bioavailability studies are excluded from the definition of 'clinical investigations' within this provision.
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Status:
Expired
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Additional Information
Print number: 117_S_4378
Sponsor: Sen. Marshall, Roger [R-KS]
Process start date: 2022-06-13
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-2.5-flash-preview-04-17
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

Hatch-Waxman Improvement Act of 2022

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_4378.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2022-06-13.

What are the main provisions?

Key points include:

  • The provision regarding the approval of drugs with single enantiomers is extended until October 1, 2027.
  • Bioavailability studies are excluded from the definition of 'clinical investigations' within this provision.
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.

What is the impact of this bill?

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge.

CATEGORIES

Health