New Strategies Sought to Pay for Costly Cures

As Congressional leaders and White House policymakers assess a range of measures designed to manage or reduce outlays for prescription drugs, pharma companies and other stakeholders are weighing innovative reimbursement models for new therapies promising to cure or treat serious illnesses. Payer Powered by WPeMatico Continue reading New Strategies Sought to Pay for Costly Cures

FDA: Advancing Non-Prescription Medicines, Including CBD Products

FDA officials are proposing new rules, beefing up regulatory resources, and promoting digital technologies to support the development and marketing of safe and innovative over-the-counter (OTC) therapies. The agency and manufacturers continue to hope that Congress will approve legislation author Powered by WPeMatico Continue reading FDA: Advancing Non-Prescription Medicines, Including CBD Products

FDA After Gottlieb: Thorny Issues, Political Challenges

During the nearly two years that Scott Gottlieb headed FDA, the agency achieved record approval rates for new drugs and generics and advanced important innovations in clinical research and benefit/risk assessment to enhance R&D and competition in the biopharmaceutical industry. The agency is Powered by WPeMatico Continue reading FDA After Gottlieb: Thorny Issues, Political Challenges

Administration Acts Fast to Smooth Transition to New FDA Commissioner

Health and Human Services (HHS) Secretary Alex Azar wasted little time in naming a new leader for FDA. Norman (Ned) Sharpless, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), will become acting commissioner next month as Scott Gottlieb departs the agen Powered by WPeMatico Continue reading Administration Acts Fast to Smooth Transition to New FDA Commissioner