Food & Drug Law Blog

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Purity or Purely Political: New York AG’s Dietary Supplement Science Fiction Feeding a Class Action Frenzy

Written by Michael A. Walsh and Katherine McGahey on February 6, 2015

Buyer Beware or Seller Beware? “This investigation makes one thing abundantly clear: the old adage ‘buyer beware’ may be especially true for consumers of herbal supplements,” said Attorney General Schneiderman in his February 3, 2015, press release. This is followed by endorsements from New York State Senator Ken LaValle, who has sponsored legislation to establish Read More…

Social media

FDA’s Social Media Oversight: An Ounce of “Cure” is Worth a Pound of Enforcement

Written by Michael A. Walsh on February 2, 2015

The House Energy and Commerce Committee released a draft of its 21st Century Cures Act  (the Cures Act) on January 27, 2015, as a “starting point in the legislative process and to spur discussion.” The draft is part of a 2014 initiative established to revamp some of what the Food and Drug Administration (FDA) regulates, Read More…

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Annual Reporting The Food and Drug Administration (FDA) recently issued a Draft Guidance entitled “Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.”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…