This post was co-authored by Megan E. McWaters, a Reed Smith summer associate. In a unanimous decision, the U.S. Supreme Court overturned...
Reed Smith LLP
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...
The U.S. Supreme Court heard arguments yesterday in the two consolidated cases challenging the U.S. Food and Drug Administration (FDA)...
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...
On April 7, 2023, only minutes apart, two federal district courts issued rulings on cases challenging the Food and Drug Administration’s...
On September 27, 2022, FDA announced the publication of a final guidance document entitled Clinical Decision Support Software, Guidance...
On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes...
A substantial shift for genetically engineered (“GE”) food regulation may be on the horizon thanks to a USDA proposed rule with a fast...
The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising...
On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an...
On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing,...
The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s...
On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by...