Sponsors of extra-U.S. trials need to carefully monitor the FDA’s requirements for the submission of foreign data.
The administration’s most recent release clears up what is necessary for developers to successfully approach specialized medical device advisory committee (MDAC) panels.
Total shoulder arthroplasty (TSA) is becoming increasingly more common as a treatment for disabling pain or impaired shoulder function. Dr. Jonelle Petscavage, a Medical Metrics’ (MMI) consultant, recently published a two-part review in the American Journal of Roentgenology on the current state-of-the-art in shoulder arthroplasty. Covering topics such as epidemiology, history, preoperative imaging, hemiarthroplasty, anatomic …
