We are pleased to announce the release of the newly updated edition of the Practicing Law Institute (PLI) Medical Devices Law and … more
KKB Partner Suzan Onel will be speaking at American University Washington College of Law’s Health Law and Policy Summer Speaker Series on … more
On September 23, 2020, FDA published a proposed rule that would amend its medical product “intended use” regulations. This proposal raises some … more
Bloomberg BNA Publications published an article on September 13, 2017, indicating that FDA expects to meet the statutory timeline of November 8 … more
This week, the U.S. Food and Drug Administration (“FDA” or “Agency”) announced it is further delaying by one year the effective date … more
On December 13, 2016, President Obama signed the 21st Century Cures Act (Public Law No. 114-255) (“the Act”) into law. This sweeping … more