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You are here: Home / Archives for FDA

FDA’s Proposed Regulatory Changes to Laboratory-Developed Tests (LDTs)

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.
Read more

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

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