News
Digital omnibus on AI regulation – Considerations for Life Sciences companies
20 November 2025
Representative experience
We have filed numerous RFDs that successfully persuaded FDA to regulate our client’s device-drug combination product in the device center.
One of our partners was invited by the FDA to speak at an agency workshop on the regulation of innovative drug delivery systems.
Another of our partners, during his time as an FDA associate counsel, was an advisor to the chief ombudsman on combination product matters.
