As someone who spent the last seven years working at the Center for Devices and Radiological Health (CDRH), I can tell you that the underlying relationship between your company and its review division really matters – from submission, through a potential Advisory Committee meeting and beyond to your medical device…

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Preparing a New Drug Application (NDA) or Pre-Market Approval (PMA) is one of the most arduous tasks regulatory teams have to face – and thinking about a possible Advisory Committee (ADCOM) meeting at the same time may seem impossible. But approaching NDA/PMA preparation with the possibility of an Advisory Committee meeting in mind not only improves a Sponsor’s chances at an ADCOM – it could prevent one from ever happening.

Here are five tips on how to approach NDA/PMA preparation with a possible ADCOM in mind.

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For pharmaceutical or device company teams, there is one common thread for all FDA meetings: the need to tell a clear story and to set the data or issue in context. Just as FDA has a process for determining whether a drug or device should be approved, companies need a proven process to keep their team on track and prepare in the most efficient and effective way. Our process includes these seven steps.

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