🚀 The Traveling to De Novo Land by eSTAR Workshop is boarding soon! If you haven't done so yet, get your ticket now and join us on this journey on Thursday December 4!
🧠 De Novo's are currently one of the most challenging pathways to commercialization in the US - don't embark on this journey without learning tips presented by the hashtag#FDA expert speakers including De Novo Program Lead Peter Yang and Assistant Director for Tools and Templates (eSTAR developer) Patrick Axtell, as well as hashtag#Industry expect speakers from DuVal & Associates, PA, Lisa Pritchard, Aaron Hage, and Kathy Herzog!
Key Topics Covered:
✈️ What is a De Novo and when should you consider one?
💼 Timelines, costs, and business implications?
🧭 How to prepare and submit a De Novo using the eSTAR templates?
🔍 What to expect during the FDA review process?
⚙️ How current FDA initiatives and administrative changes may affect your De Novo flight path?
✈️ Get your ticket (registration) and details here: https://lnkd.in/gaxfTEgA
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Lisa Pritchard FRAPS
VP of Regulatory, Quality, Clinical and Engineering
DuVal & Associates PA
Bloomington MN
United States
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