By Roz Sweeney, Ph.D., Nerac Analyst
Originally Published: November 17th, 2014
The FDA has stated that labs can utilize published clinical data for their submissions. Many LDTs have been on the market for a while and have significant published data. Nerac has expertise in conducting clinical literature evaluations and data analysis to support regulatory filings and ongoing regulatory requirements. Read More
In Vitro Diagnostics – Upcoming Regulatory Developments in the U.S. and European Union: Are You Ready for the Transition?
by Roz Sweeney, Ph.D. and Donna Mitchell-Magaldi, Nerac Analysts
Originally published October 2, 2014
Join Nerac analysts Roz Sweeney and Donna Mitchell-Magaldi in this free, interactive webinar providing an overview of the upcoming regulatory changes affecting the In Vitro Diagnostics industry. Read more
Bringing Functional Foods to Market: FDA’s Regulatory Mandate Drives the Process
Originally published February, 2011
Bringing a new functional food product to market is a potentially complex process with many decision points driven by the US Food and Drug Administration’s (FDA) regulatory mandate.
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Utilizing the FDA Website for Competitive Intelligence Information
By Donna Mitchell-Magaldi, Nerac Analyst
Originally published April, 2014
There are many resources available when gathering competitive intelligence. Read more