Panoramic: Automotive and Mobility 2025
Advisory Panel Preparation
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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 navigate the panel preparation process, we are ready to help you navigate the process to obtain a successful outcome. Using our broad experience, we help anticipate potential panel and FDA questions, craft persuasive briefing documents, prepare experts for testimony, and coordinate a cohesive and compelling presentation of the clinical data.
We also have extensive experience preparing companies for issues-focused panel meetings that are not product specific, as well as reclassification panel meetings.
Our capabilities at a glance
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Judicial review wins
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Ex-government policy advisors
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Key contacts
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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