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Biodesign Workshops

Regulatory & Clinical Strategy- How to Navigate the FDA

October 17, 2017
6:00 pm
October 17, 2017
7:30 pm

Sure, your invention is amazing, and your business plan is solid, but before your product ever reaches a patient, you need to get regulatory approval. We'll introduce you to Allison Komiyama, a former FDA reviewer and discuss what it's like dealing with the FDA today (hint: it's not as bad as you think). We'll also cover strategies for getting approval outside the US and how your path might be different depending on whether you're in Health IT, Med Devices, Biotech, or Pharma.

  • ā€¨Regulatory Timeline
  • Navigating FDA Guidance
  • Drugs vs Devices vs Heath IT
  • Case Studies
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