Regulating Cell Therapies: Conditional Approval Under Consideration In Congress; FDA Plans Public Hearing
This article was originally published in RPM Report
Executive Summary
Does FDA need a new pathway to consider advances in cellular therapy? Some in Congress think so. FDA is inviting stakeholders to weigh in this fall.
You may also be interested in...
Will US FDA User Fee Reauthorization Bring More RATS?
Congress should broaden scope of the 21st Century Cures’ regenerative advanced therapies (RAT) program to include gene therapies and other innovative treatments for rare diseases, attorney Sasinowski says, suggesting such an expansion could be part of the PDUFA legislation.
Regenerative Medicine In Cures: Conditional Approval Dropped In Lieu Of ‘Breakthrough’-Style Approach
Push to open up new US pathway for regenerative medicine helped the 21st Century Cures bill make it to the finish line in the lame duck Congress – but only after the proposal has been dramatically revised to fit into the established BLA pathway.
NIH Funding Component of 21st Century Cures May Get White House Boost
Vice President’s Cancer Moonshot project could provide final thrust for '21st Century Cures' bill in the lame duck Congressional session after election.