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FDA Issues COVID-19 Policy for Certain Digital Health Solutions

USA - April 18 2020 On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric…

Wade Ackerman

FDA Reopens Cannabis Docket

USA - March 11 2020 FDA has reopened the comment period indefinitely for its public hearing on Products Containing cannabis or cannabis-derived compounds.In doing so…

Wade Ackerman, Miriam Guggenheim, Jessica P. O'Connell, Jeannie Perron

FDA Submits CBD Report to Congress

USA - March 6 2020 Yesterday, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on the agency’s evaluation of potential…

Miriam Guggenheim, Jessica P. O'Connell, Jeannie Perron, Ben Weksberg

Lawyers, Ask These 10 Questions During Digital Health Ideation

USA - January 27 2020 Lawyers, Ask These 10 Questions During Digital Health Ideation…

Elizabeth H. Canter, Joshua Gray, Wade Ackerman, Sarah Cowlishaw, Rujul Desai, Priscilla Fasoro, Sarah A. Franklin, Maree Gallagher, Nigel Howard, Anna Kraus, Christina G. Kuhn, Jessica L. Parezo, David Wildman

HHS and FDA Release Proposed Rule and Draft Guidance on Importation of Drugs Originally Intended for Foreign Markets

Canada, USA - December 19 2019 On December 18, 2019, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a notice of proposed…

Krista Hessler Carver, Thomas J. Cosgrove, Julie Dohm