An increase in applications for gene therapies is putting stress on FDA’s resources.
Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.
Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.
FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.
Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?
The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.
FDA aims to address mounting criticisms of its accelerated approval pathway.
FDA has spurred investment to create and develop 600 therapies.
A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.