arrow_back Back to App

New Rules for Accelerated Drug Approval: Increased Transparency and Oversight

This act changes how drugs for serious diseases get accelerated approval. It requires drug companies to conduct follow-up studies after approval to confirm effectiveness and mandates regular reporting on study progress. The goal is to ensure that drugs approved quickly are safe and effective for patients.
Key points
Companies must conduct studies to confirm a drug's effectiveness after accelerated approval, unless the FDA provides a reason not to.
The FDA will set the conditions for these studies (e.g., enrollment targets, timeline) at the time of drug approval.
The FDA can require confirmation studies to be underway before a drug is approved.
Faster procedures are established for withdrawing a drug if the company fails to conduct required studies or the drug doesn't show expected effectiveness.
Companies must report study progress to the FDA regularly (every 180 days), and this information will be made public.
Failure to conduct studies or submit reports will be considered a violation of the law.
article Official text account_balance Process page
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 117_S_4446
Sponsor: Sen. Collins, Susan M. [R-ME]
Process start date: 2022-06-22
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-2.5-flash-preview-04-17
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

Modernizing the Accelerated Approval Pathway Act of 2022

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_4446.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2022-06-22.

What are the main provisions?

Key points include:

  • Companies must conduct studies to confirm a drug's effectiveness after accelerated approval, unless the FDA provides a reason not to.
  • The FDA will set the conditions for these studies (e.g., enrollment targets, timeline) at the time of drug approval.
  • The FDA can require confirmation studies to be underway before a drug is approved.
  • Faster procedures are established for withdrawing a drug if the company fails to conduct required studies or the drug doesn't show expected effectiveness.
  • Companies must report study progress to the FDA regularly (every 180 days), and this information will be made public.
  • Failure to conduct studies or submit reports will be considered a violation of the law.
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. Collins, Susan M. [R-ME].

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