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FDA Reauthorization Act: Drug and Medical Device Fees Extended

This act extends user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products until 2027. The changes aim to expedite the approval process for new products, potentially leading to faster access to innovative therapies and medications for citizens. It also introduces new rules regarding fees and their use by the Food and Drug Administration (FDA).
Key points
Extends FDA funding through fees from pharmaceutical and medical device companies until 2027.
Modifies how fees are calculated and used, aiming to streamline drug and device approval processes.
Introduces new definitions and exceptions for fees, such as for skin-test diagnostic products.
Reauthorizes programs supporting the development of pediatric drugs, orphan drugs, and innovative medical devices.
article Official text account_balance Process page
Expired
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Additional Information
Print number: 117_S_4535
Sponsor: Sen. Burr, Richard [R-NC]
Process start date: 2022-07-14
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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

FDASRA Act of 2022

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_4535.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2022-07-14.

What are the main provisions?

Key points include:

  • Extends FDA funding through fees from pharmaceutical and medical device companies until 2027.
  • Modifies how fees are calculated and used, aiming to streamline drug and device approval processes.
  • Introduces new definitions and exceptions for fees, such as for skin-test diagnostic products.
  • Reauthorizes programs supporting the development of pediatric drugs, orphan drugs, and innovative medical devices.
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. Burr, Richard [R-NC].

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