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Amarin/Caronia: What Lies Ahead for Tort Preemption?

Written by Michael A. Walsh on August 11, 2015

In a strange coincidence, the death of Frances Oldham Kelsey on August 7, 2015 coincided with the release of the decision in Amarin v. FDA, 1:15-CV-03588-PAE, Doc. 73 (SDNY Aug. 7, 2015). Ms. Kelsey is generally credited with the regulatory changes that require evidence of efficacy before a product can be marketed for a specific Read More…


D’oh! Is the FDA Banning Donuts?

Written by Michael A. Walsh on June 16, 2015

Protecting the Public from Itself: FDA Bans Trans Fat More than 100 years after its formulation, partially hydrogenated oil (PHO), an American staple, will soon be relegated to the hazardous waste bin. On June 16, 2015, in its Final Determination Regarding Partially Hydrogenated Oils, the Food and Drug Administration’s (FDA’s) Center for Food Safety and Read More…

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Parallel Claims – the Government’s Position revealed in Allergan v Athena

Written by Michael Walsh on June 9, 2015

A Clarion call for an industry poised to win the battle but lose the war? We said it before and it bears repeating: there is something inherently troubling when a prescription drug manufacturer wants a jury to decide a product claim under state law that should be decided by the Food and Drug Administration (FDA) Read More…

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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…