PDUFA V: Accelerated Approval Expansion May Outshine Rare Disease Improvements
Executive Summary
Rare disease advocate says the focus should be on ensuring the accelerated approval expansion and surrogate endpoint guidances become FDA priorities as the rare disease drug program is set to grow under PDUFA V.
You may also be interested in...
Cures II Wish List: Reconsidering Accelerated Approval?
Richard Pazdur wants the oncology community to take a fresh look at US FDA’s expedited review programs. One big question: should there be fewer of them?
Accelerated Approval: Avastin, Makena Bookend A Watershed Decade For US FDA’s Expedited Pathway
Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
'Progressive Approval' Coming? US FDA Considers Accelerated Approval Without Surrogates
Commissioner Gottlieb tells Congress that concept could be used for some clinical endpoints when a large benefit is seen in a small trial, which could benefit rare disease drug development.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: