Area of focus

Combination Products, FDA Jurisdictional Issues, FDA Postmarket Compliance Issues

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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.

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Key contacts

Jonathan S. Kahan

Jonathan S. Kahan

Partner
Washington, D.C.

Janice M. Hogan

Janice M. Hogan

Partner
Philadelphia, Washington, D.C.

John J. Smith, M.D., J.D.

John J. Smith, M.D., J.D.

Partner
Washington, D.C.

Randy J. Prebula

Randy J. Prebula

Partner
Washington, D.C.

Jodi Scott

Jodi Scott

Partner
Denver




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Related practices

Medical Device and Technology Regulatory
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