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Documents by Lawyers at this office
FDA Explores Use of Term "Natural" on Human Food Labeling
Edgar J. Asebey,Jonathan Berman,Colleen Heisey,Katherine M. Llewellyn,Cristiana Spontoni, November 27, 2015
FDA is requesting public comments on (i) whether it is appropriate to define the term "natural" and, if so (ii) how the agency should define "natural," and (iii) whether it should determine appropriate use of the term on food labels. FDA considers a human food to be...
FDA Holds Back-to-Back Workshops on Next-Generation Sequencing Diagnostic Tests
Edgar J. Asebey,Maureen Bennett,Christian B. Fulda,Colleen Heisey,Cristiana Spontoni, November 27, 2015
Last week, FDA held two workshops to gather information on developing a flexible approach for the regulation of next generation sequencing ("NGS") in vitro diagnostic tests. NGS tests facilitate the rapid sequencing and analysis of segments of DNA, yielding information that can be used to...
FDA Publishes Three Major FSMA Final Rules
Edgar J. Asebey,Jonathan Berman,Colleen Heisey, November 27, 2015
On November 13, 2015, the U.S. Food and Drug Administration ("FDA") published the three major rules affecting the food industry that it will adopt in 2015. These include final rules on Foreign Supplier Verification Programs ("FSVP"), Accredited Third-Party Certification, and...
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