The U.S. Department of Health and Human Services (HHS) has announced a new general policy on what factors the agency will take into...
Reed Smith LLP
The fallout from last week’s Loper Bright/Relentless opinion by the U.S. Supreme Court that prospectively eliminated Chevron deference is...
On May 14, 2024, FDA hosted a webinar to provide an overview of its final rule “Medical Devices; Laboratory Developed Tests” as well as...
Elliott is a law clerk at the firm and his work is supervised by licensed attorneys. His admission to the New York bar is pending. During...
On October 31, FDA will be offering a webinar on its proposed rule ”Medical Devices; Laboratory Developed Tests.” This webinar comes...
On September 15, 2023, FDA published an update to the guidance document – “Breakthrough Devices Program, Guidance for Industry and Food...
On August 1, 2023, the U.S. Food & Drug Administration (“FDA”) and the Drug Enforcement Administration (“DEA”) issued a joint letter to...
Note: This is Part 2 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its...
Note: This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its...
[Note, this is Part 2 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L....
On September 27, 2022, FDA announced the publication of a final guidance document entitled Clinical Decision Support Software, Guidance...
The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”)...
On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an...