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


Expedited Approval Pathway Concept Draws Strong Support But Different Proposals

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Debate at a recent cancer research meeting reflects the challenges that lay ahead, and the diverging viewpoints that will have to be balanced, in creating any new approval mechanism.

You may also be interested in...

Untargeting Xalkori? Hints Of Efficacy In ALK-Negative Patients Must Be Addressed, FDA Says

FDA approved Pfizer’s lung cancer drug for patients positive for the gene translocation – but review documents show that agency reviewers focused on the efficacy seen in the few ALK-negative patients in the pivotal trial, and want Pfizer to follow up on that signal post-marketing. Regulatory expectations for disproving effect in the non-selected population will be an important issue as more personalized medicines reach the agency.

Accelerated Approval Could Expand As Alternative To Progressive Approval

CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.

FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill

Legislation being drafted by Sen. Kay Hagan, D-N.C., would formalize FDA practices of approving drugs in certain circumstances where the evidence needed for a standard approval cannot be generated.

Related Content


Related Companies

Latest Headlines
See All



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