1. Pink Sheet

GOP Accelerated Approval Proposal Could Expand Eligibility For US FDA Pathway

 
• By Derrick Gingery

The rival to House Energy and Commerce Committee Chair Frank Pallone’s bill would not set expiration dates for accelerated approvals.

US Capitol
The Republican proposal would allow sponsors to create a clinical development plan with the FDA to provide more clarity and certainty. • Source: Alamy

A Republican accelerated approval reform proposal attempts to expand eligibility for the US Food and Drug Administration’s expedited pathway and eschews automatic expiration dates for product clearances.

Current law states that the FDA can approve a product using the pathway upon a determination of an effect on a surrogate endpoint reasonably likely to predict clinical benefit or...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legislation

More from Pink Sheet

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.