Area of focus

Combination Products, FDA Jurisdictional Issues, FDA Postmarket Compliance Issues

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.

Hogan Lovells Publications

FDA addresses industry feedback on routine inspections by formalizing processes and standards in a draft guidance Medical Device Alert

On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection...

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