Ashley Grey
Hogan Lovells
Articles
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…
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…
