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
In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms focused on FDA bundled under Title...more
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more
On January 6 of this year, the Food and Drug Administration (FDA) released a final guidance on the Safer Technologies Program (STeP) for Medical Devices. The concept of STeP was first introduced by FDA in 2018 with the goal...more
On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...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
On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs.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
On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices. The proposed rule would require that...more