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read by leaders in industry, finance, and government worldwide.

 

SNS Subscriber Edition Volume 18, Issue 9 Week of March 2, 2014

 

 

 

***SNS***

 

Special Letter:

An Innovator's Handbook: Dealing with the FDA

 

 

 

In This Issue

 

 

Feature:

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

 

Inside SNS

 

Upcoming SNS Events

 

Where's Mark?

 

[Please open the attached .pdf for best viewing.]

 

   By Dr. Corinna E. Lathan

 

_____

 

Five Global Challenges

 

IV: The Failure to Self-Govern

 

 

Is this what democracy looks like? Unlikely. Mark Anderson delves into the basic problems in politics today, and how to solve them - as part of the Park City Institute / SNS / "Future in Review" Speaker Series.

 

Watch now.

 

 

 

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. 

 

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