SEC Activity with Fixed Income and Credit Funds
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
On July 30, the US Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT), a new science-based tool designed to screen and evaluate the safety or toxicity of chemicals in food....more
On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software. ...more
Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance...more
Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more