The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion that relates...
Reed Smith LLP
Note: This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its...
On February 28, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory...
[Note, this is Part 2 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L....
On December 28, 2022, the Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable advisory opinion...
Can a hospital be sued as a seller in a pharmaceutical product liability action? That may be the case in Oregon as a result of a recent...
Last month’s leaked U.S. Supreme Court draft majority opinion from Justice Alito in Dobbs v. Jackson Women’s Health Organization that...
On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes...
The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”)...
On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. §...
On June 30, 2020, United States Senators Elizabeth Warren (D-Mass.) and Marco Rubio (R-Fla.) introduced legislation proposing the...