1. Pink Sheet

User Fee Add-Ons: Senate Bill Tweaks Orphans, Opioids, Patient Data

 
• By Nielsen Hobbs

Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.

Capitol House

The user fee legislation that the Senate HELP Committee will markup on May 10 is mostly the bland, renewal-only document (a "clean" bill in legislative parlance) that circulated last month, but a manager's amendment released May 8 gives a sense of where senators, while not exactly getting their hands dirty, have decided to nudge FDA.

The additions have mostly avoided the controversial topics of the day, even as the bill now skirts the pricing debate by touching on importation. (See sidebar for related story and...

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.