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Drug Safety Updates – Regulations and FDA Guidance for Industry

By Stephen Buxser, Ph.D., Nerac Analyst
Originally published November 28, 2016
For drugs licensed for sale in the United States, as well as elsewhere in the world, there are requirements for periodic literature updates/reviews. This article describes the legal requirements for drug safety and efficacy reporting.
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Defining “Natural” in Food Labeling – Why does it matter?

By Helga Weires, Nerac Analyst
Originally published October 13, 2016
Defining the term “natural” has been a hot topic among the manufacturers, consumers and regulators of the food industry in recent years. The use of the term “natural” or “all natural” is ubiquitous on store shelves across the country, yet there has been confusion as to what this word really means in food labeling and advertising.
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Brexit: Implications on your Intellectual Property Rights

By Eden Joy Pacsial-Ong, Ph.D.
Originally published October 13, 2016
This article reviews some of the impacts of the British exit from EU, or Brexit, and the resulting uncertainty that surrounds the UK, its relationship with the EU, and the ultimate impact on trade, immigration and intellectual property (IP) laws.
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Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A 3-Part Nerac Perspective

By Richard Conforti, M.S.
Originally published August 15, 2016
This is a 3-part series of articles on the 2014 Chinese Food and Drug Administration(CFDA), providing an update on their medical device regulations. The first article discussed which devices can be used to support your submission to the CFDA. The second article addressed the changes to selecting clinical literature. The third article describes the final clinical literature report.
Read all three here