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 companies ...

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.

Hogan Lovells Publications

New FDA final guidance on medical device panel meetings provides certain changes to timelines and procedures Medical Device Alert

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or,...

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The FDA Advisory Panel Meeting: Ensuring Success in an Unpredictable Process

How do you raise the likelihood of success of your FDA Medical Device Advisory Panel meeting?

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