What was the most valuable lesson you learned in your first year of practice? My most valuable lesson was understanding regulatory agencies. Whether it’s the FDA, DEA, or a state regulatory board, a crucial part of regulatory counseling is understanding how an agency works, its primary mission and its key legal and regulatory resources.
Describe your biggest win or accomplishment in practice. I assisted ImPACT Applications in determining the FDA regulatory pathway for its software-based cognitive test systems and in preparing its FDA submission. In August 2016, the FDA granted marketing clearance for these systems, which were the first FDA-cleared devices for use in assessing cognitive function following a possible concussion.
