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Drug Supply Chain – July 1, 2015 Deadline for Dispensers

Written by Michael A. Walsh on May 19, 2015

On May 18, 2015, the Food and Drug Administration posted “From our Perspective” providing materials for dispensers subject to the November 2013 Drug Supply Chain Security Act (DSCSA). The FDA’s website was recently updated with a copy of a webinar and PowerPoint presentation entitled Know Your Source posted by the FDA’s Division of Drug Information Read More…

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For Whom the Blue Bell Tolls: Blue Bell Takes a Major Step Forward

Written by Michael Walsh on May 14, 2015

After its initial poor response to the major media firestorm ignited by the deaths and illnesses linked to its products, Blue Bell has made significant steps towards restoring consumer confidence by conducting a nationwide recall of its entire product line. On May 14, 2015, Blue Bell entered into a comprehensive agreement with the Texas Department Read More…

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Trying to Infuse® Common Sense into Parallel Claims and Off-Label Promotion

Written by Michael A. Walsh on May 11, 2015

Why is it that the Food and Drug Administration (FDA) is suggesting it will conduct a meeting in the summer of 2015? Perhaps the FDA has had its fill after reaping more than $12 billion in penalties. More likely the landmark decision in US v. Caronia, 703 F.3d 149 (2d Cir. 2012) was the watershed Read More…

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FDA’s Mandatory Recall Draft Guidance: What, When, Why, How and Who Pays!

Written by Michael A. Walsh on May 7, 2015

On May 7, 2015, the Food and Drug Administration (FDA) published its draft Guidance for Industry Questions and Answers Regarding Mandatory Food Recalls and opened its docket [No. FDA-2015-D-0138] seeking comments. The Food Safety Modernization Act of 2011 (FSMA) granted the FDA extensive new power to require recall for food products (including finished products and Read More…


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…