Posts

FDA Commissioner Makary Warns of US Lagging Behind China in Biotech Amid Proposed Budget and Reforms

Makary Proposes Higher FDA User Fees for Non-US Phase I Trials to Counter China Biotech

Despite Government Shutdown, Companies Still Plan to Submit FDA Applications

US Government Shutdown Threatens to Stress an Already Depleted FDA

FDA Chief Calls for Lower User Fees as PDUFA VIII Negotiations Begin