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.
Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.