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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Annual Reporting The Food and Drug Administration (FDA) recently issued a Draft Guidance entitled “Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.”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for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information” (IE Draft Guidance). It is a Draft Guidance in name only, because FDA intends to treat it as final. The IE Draft Guidance Read More…

Menu board

Restaurants & Retail Food Stores: The FDA is on its Way; “Misbranding” is a Crime

Written by Michael A. Walsh on November 26, 2014

The Food and Drug Administration (FDA) issued a 395 page Final Rule on Food Labeling entitled the “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” (the “Menu Labeling Rule”). FDA didn’t come up with the idea for Menu Labeling Rule on its own. Section 4205 of the Patient Protection and Read More…

Computer doctor

FDA Releases Guidance on Medical Device Cybersecurity

Written by Debra L. Innocenti and Michael A. Walsh on October 9, 2014

The Food and Drug Administration (FDA) has issued its final guidance on cybersecurity functionality and safety controls, establishing considerations for the design, development and premarket submissions related to medical devices. The FDA issued an earlier draft of the guidance on June 14, 2013. The guidance responds to the rapid evolution of medical devices into special Read More…