1. Pink Sheet
  2. >>Geography
  3. >>Europe

User Fee Conference Committee Targets Settling Differences In June

A conference committee tackles differences between House and Senate FDA user fee and agency reform bills, with an agreement expected before the end of June.

The House and Senate both avoided contentious issues in passing separate user fee bills with broad support, leaving questions about drug- and device-related fees for a conference committee to resolve. But the differences in H.R. 5651, the FDA Reform Act, and S. 3187, the FDA Safety and Innovation Act, could make it difficult for conferees to compromise within the deadline set by House and Senate leaders, who want to send the legislation to President Obama by the end of June. Below are differences in the bills’ drug-related provisions and possible outcomes of the conference process.

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 Europe

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 
• By Francesca Bruce

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

Gilead’s Lenacapavir Up For EMA Verdict Amid Packed CHMP Meeting Agenda

 
• By Vibha Sharma

The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.

Gene Therapy Elevidys Among Six Orphan Drugs Awaiting EU Marketing Verdict

 
• By Vibha Sharma

The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.

More from Geography

Gilead’s Lenacapavir Up For EMA Verdict Amid Packed CHMP Meeting Agenda

 
• By Vibha Sharma

The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.

Gene Therapy Elevidys Among Six Orphan Drugs Awaiting EU Marketing Verdict

 
• By Vibha Sharma

The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.