SNS Subscriber Edition Volume 18, Issue 9 Week of March 2, 2015 In This Issue
SNS: Special Letter: An Innovator’s Handbook: Dealing with the FDA
Step 1: Concept Definition
Step 2: Product Risk
Step 3: Dialog with the FDA
Step 4: The Paperwork
Step 5: Getting to Market
Conclusion
About Corinna E. Lathan
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Publisher’s Note: We have been delving into the future of biology, genetics, healthcare, evolutionary theory, biofeedback systems, neurophysiology, brain-inspired computing, the Quantified Self, and medical software and devices for at least a decade. But nowhere during this thread have we touched on what is often the life-or-death issue for entrepreneurs in these arenas: dealing with US regulatory agencies.
In this discussion, for the first time in our history, we’re providing a deep dive into the do’s and don’ts of this process, in perhaps the toughest product approval agency: the Food and Drug Administration. As many SNS members are aware, the challenges behind gaining entry to the US markets where this agency has sway are so daunting that many companies, both large and small, have turned to other international markets (Germany perhaps being first) as a quicker, cheaper way to early markets.
What do entrepreneurs – and F500 CEOs – need to know about getting this done right? Read on. – mra.
