On May 14, 2024, FDA hosted a webinar to provide an overview of its final rule “Medical Devices; Laboratory Developed Tests” as well as...
Reed Smith LLP
On October 31, FDA will be offering a webinar on its proposed rule ”Medical Devices; Laboratory Developed Tests.” This webinar comes...
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...
On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device...
On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. §...
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On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing,...
On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by...