Results 1 to 4 of 4

FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

USA - March 23 2023 The U.S. Food and Drug Administration (FDA) - in collaboration with the University of Maryland Center of Excellence in Regulatory Science and…

Robert Church, Cybil Roehrenbeck, Blake Wilson

After the Public Health Emergency: Implications for Medicare and U.S federal health care policies

USA - March 13 2023 On January 30, 2023, the Biden Administration announced that it intends to allow the COVID-19 national emergency and public health emergency…

Mike Dohmann, Jessica Robinson Hanna, James Huang, Lindsey Johnson, Katie Kramer, Rianna Modi

MEDCAC Coverage with Evidence Development meeting offers CMS guidance on CED study requirements

USA - February 23 2023 On February 13-14, 2023, the Centers for Medicare & Medicaid Services (CMS) convened a virtual panel of the Medicare Evidence Development & Coverage…

Beth Halpern, Stuart Langbein, Cybil Roehrenbeck, Victoria M. Wallace

O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

USA - January 19 2023 Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a…

Mike Druckman, Meredith Manning