1. Pink Sheet
  2. >>Market Access

Expanded Access: US FDA Application Data Suggest More Project Facilitate Outreach Needed

 
• By Derrick Gingery

Academic medical centers still submit the vast majority of applications to the FDA Oncology Center of Excellence’s expanded access program, suggesting many community hospitals and other providers may perceive barriers to the program.

cancer detection
OCE wants all oncologists to know they can use the expanded access program. • Source: Shutterstock

Oncology expanded access applications continue to emerge largely from academic institutions, which may prompt the US Food and Drug Administration’s Oncology Center of Excellence to continue boosting its outreach so providers in other settings may take advantage of the program.

Project Facilitate was created to help providers navigate the expanded access program. Agency officials will help providers complete the application and set up the necessary controls to use an unapproved...

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 Market Access

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.