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GMO Corn

Genetically Modified Corn – a Litigation Commodity

Written by Jessica Bresler and Michael A. Walsh on January 19, 2015

Foods have been modified naturally and through breeding techniques for thousands of years. Advances in natural or conventional breeding techniques flourished in the 20th century and, among other things, increased yield, addressed pest issues and created specific nutrient attributes. Advances in science led to the development of recombinant deoxyribonucleic acid (DNA) technology and what is Read More…

Box of medicine

From Mayday! to May Day: FDA Extends Enforcement Deadline for DSCSA Track and Trace Compliance until May 1, 2015

Written by Michael A. Walsh on December 30, 2014

On the night before the night before Christmas, the Food and Drug Administration (FDA) did what it could to lessen anxiety in the drug industry by issuing a Final Guidance entitled DSCSA [Drug Supply Chain Security Act] Implementation: Product Tracing Requirements – Compliance Policy. According to this Guidance, FDA intends to delay enforcement of the Read More…

Supply chain management

Drug Wholesaler and Third-Party Logistics Provider Licensing and Reporting: FDA issues Guidance Documents

Written by Michael A. Walsh on December 18, 2014

Annual Reporting The Food and Drug Administration (FDA) recently issued a Draft Guidance entitled “Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.” guidance outlines the annual reporting requirement for Third-Party Logistics Providers (3PLs) which began on November 27, 2014 and for prescription drug wholesale distributors (Wholesale Distributors) Read More…

Sugar bowl

Whole Foods’ Greek Yogurt: Federal Labeling Requirements and Class Actions

Written by Michael A. Walsh on December 16, 2014

On December 10, 2014, the Judicial Panel on Multidistrict Litigation granted the parties’ request to centralize nine actions pending across the country in the Western District of Texas—Whole Foods’ home state.  According to the plaintiffs, Whole Foods misrepresented the sugar content on the nutritional labels of its Whole Foods Market 365 Everyday Value Plain Greek Read More…

The Drug Supply Chain Initial Standards for Interoperable Exchange

Written by Michael A. Walsh on December 1, 2014

FDA served up some turkey on Thanksgiving Day, issuing its “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information” (IE Draft Guidance). It is a Draft Guidance in name only, because FDA intends to treat it as final. The IE Draft Guidance Read More…