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
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