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FDA addresses industry feedback on routine inspections by formalizing processes and standards in a draft guidance Medical Device Alert

04 April 2019

On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection...

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

Key contacts

Jonathan S. Kahan

Partner
Washington, D.C.

Janice M. Hogan

Partner
Philadelphia, Washington, D.C.

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

Partner
Washington, D.C.

Randy J. Prebula

Partner
Washington, D.C.

Jodi Scott

Partner
Denver

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98SHc42/Fo0TuOypSOglKFwDaQYaUEgVFhKsAZCzoXY= {D4BD31A6-3DC4-40F3-A842-496ECD1CC33D} 98SHc42/Fo0TuOypSOglKFwDaQYaUEgVFhKsAZCzoXY= {B83F4964-0075-4D1D-BD72-D13588848DE8} What would you like to discuss?

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Combination Products, FDA Jurisdictional Issues, FDA Postmarket Compliance Issues

Representative experience

FDA addresses industry feedback on routine inspections by formalizing processes and standards in a draft guidance Medical Device Alert

FDA statement underscores continued emphasis on use of real-world evidence in active postmarket device surveillance Medical Device Alert

Key contacts

Related practices