Hogan Lovells Publications
FDA statement underscores continued emphasis on use of real-world evidence in active postmarket device surveillance Medical Device Alert
29 November 2018
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.
