How to Prepare for FDA Submissions and Communicate Them With the FDA

A medical device company making a submission to the FDA on any of these: INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, and Post-Approval Supplements; needs practice and learning of all the intricate aspects of these activities. The FDA approval is necessary to start legal manufacturing a medical device or a combination product in the US. […]