On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more
Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big...more
On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly...more
Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration has the responsibility to...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more