Archive for April 2018

Tips & Tricks: Regulatory Path

Create an outline of the regulatory plan that will enable marketing approval of your technology/product. Determine which FDA division is likely to have oversight for development and approval by visiting www.fda.gov as direct consultation with the appropriate FDA Division is an essential step to ensure the smoothest possible design and conduct of a development plan…

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Specialist Series: The Regulatory Path

Contributed by John Randle, Phd B-BIC COACH PRINCIPAL, RANDOM WALK VENTURES, LLC COO, KANTUM BIO   Most new technologies and products will require regulatory scrutiny and approval prior to marketing.  These requirements vary widely depending on the nature of the technology/product and their intended medical use, as well as the regulatory precedent set by existing…

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