Companies focus on FDA for submissions to market their products, but both informal and formal engagement early and often with the Agency can actually help accelerate the product development pathway and shape marketing claims well ahead of the actual clinical study or marketing submission. Navigating those first interactions with FDA can be daunting and raise a lot of questions:
- Why would you do a pre-submission for your medical device and what does the De Novo pathway involve?
- What is TAP?
- Does an IDE mean many years and multi-millions for product approval?
- What about combination products?
This Webinar will help you orchestrate your interactions with FDA to understand the most expeditious yet realistic pathway to medical device or combination product market authorization. We will describe the processes and also tips for success in preparing and executing FDA meetings and submissions. While we will focus on medical devices, we will include special considerations for combination products.
Speakers:
Laura Rose, PhD, Engagement Partner Regulatory Affairs, Bruder Consulting & Venture Group
Susan Drapeau, PhD, Vice President, Bruder Consulting & Venture Group