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Area of focus

Advisory Panel Preparation

You’ve spent many years developing and testing your product to bring it to market. A make-or-break step in this process can be securing a positive recommendation from the relevant U.S. Food and Drug Administration (FDA) advisory panel. To achieve that goal, preparation is essential.

Having assisted numerous...

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Representative experience

Despite client’s 2 non-approvable letters before our work, we helped with PMA amendments & secured unanimous Advisory Panel approval recommendation.

Ran PMA & Advisory Panel process & gained approval for novel, non-invasive screening test using advanced DNA technology detecting colorectal cancer.

Managed PMA & Advisory Panel Process & facilitated approval for novel tissue glue product that removes need for abdominoplasty post-surgical drains.

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Key contacts

Gerard J. Prud'homme

Gerard J. Prud'homme

Senior Counsel
Washington, D.C., Baltimore

Janice M. Hogan

Janice M. Hogan

Partner
Philadelphia, Washington, D.C.

Kristin Zielinski Duggan

Kristin Zielinski Duggan

Partner
Washington, D.C.




All related lawyers

Related practices

Medical Devices and Technology Regulatory
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