Samantha Hong joins KKB from FDA’s Office of the Chief Counsel
Kleinfeld, Kaplan & Becker LLP is pleased to announce that Samantha Hong has joined the firm. Ms. Hong was previously Associate Chief … more
drug
FDA’s Regulations on “Intended Use”: One More Try
On September 23, 2020, FDA published a proposed rule that would amend its medical product “intended use” regulations. This proposal raises some … more
Off-Label Communications and Intended Use: What’s Happening Now?
This week, the U.S. Food and Drug Administration (“FDA” or “Agency”) announced it is further delaying by one year the effective date … more
21st Century Cures Act Provides (Some) Clarity on FDA’s Regulation of Software
On December 13, 2016, President Obama signed the 21st Century Cures Act (Public Law No. 114-255) (“the Act”) into law. This sweeping … more