Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Expanded Access Pilot Launching Soon With Staffing Questions Unanswered

Executive Summary

New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.

You may also be interested in...



US FDA’s Project Facilitate Making Some Improvements To Expanded Access

Analysis presented at ASCO concludes that pilot program helped physicians request access to investigational drugs for individual patients. Now agency officials are suggesting an expansion of the project.

Expanded Access Program Improving, But Sponsor Concerns Linger

Many stakeholders interviewed by the GAO find the US FDA's updated guidance on treatment of adverse event data gathered under expanded access to be helpful, but some continue to be concerned that the data will be used to negatively impact development programs.

Sarepta Tells Patients To Stand Down, Golodirsen Future 'Our Responsibility'

Patient advocates asked what they could do after US FDA’s complete response letter for the proposed Duchenne drug, but Sarepta's CEO said the company would get the product back on track to approval itself, a marked contrast to engaged role the community played the last time the firm ran into a roadblock at the agency.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS125323

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel