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FDA requests data and information at public hearing on products containing cannabis or cannabis-derived compounds

USA - June 11 2019 Last Friday (May 31, 2019), FDA hosted a public hearing on "Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived...

Jessica P. O'Connell, Miriam Guggenheim.

FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

USA - April 12 2019 In a recent post on the Covington Digital Health blog, we analyze FDA’s recently-released proposed regulatory approach for medical devices that use...

FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

USA, France - April 10 2019 On April 2, 2019, FDA released a Discussion Paper entitled “Regulatory Framework for Modifications to Artificial IntelligenceMachine Learning...

Wade Ackerman, Scott Danzis, Lindsey L. Tonsager.

FDA releases comprehensive regulatory framework for regenerative medicine

USA - November 21 2017 In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory...

Richard Kingham, Christina G. Kuhn, Wade Ackerman, Denise Esposito, Matthew Hegreness, Marienna H. Murch, Scott Cunningham, Julia F. Post.

Pharmaceutical digital health innovators take note: FDA public hearing on an innovative approach to devices referencing drugs

USA - November 15 2017 On November 16, 2017, the Food and Drug Administration ("FDA" or the "Agency") will hold a public hearing on a proposed approach for sponsors seeking...

Wade Ackerman.