PMA Submission Guide: FDA Requirements, Timelines, and Best Practices
For medical device manufacturers, the Premarket Approval (PMA) process is the most rigorous path to market in the...
July 13th, 2023
For medical device manufacturers, the Premarket Approval (PMA) process is the most rigorous path to market in the...
A Biologics License Application (BLA) is one of the most critical milestones in the development of a biologic therapy....
Generic drugs play a critical role in improving patient access and reducing healthcare costs. But bringing a generic to...