Medical Device Single Audit Program: The Basics
Recently, the Regulatory Authority Council issued a report that the Medical Device Single Audit Program (MDSAP) has been successful in its pilot, and will therefore continue. So what is the […]
What the FDA Reauthorization Act Means for Pharmaceuticals and Medical Devices
On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects […]