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Drug Law: Off-Label Use – a Paradigm Shift and a Moral Imperative

Written by Michael A. Walsh on November 21, 2016

On December 16, 2016, the State Bar of Texas will host a Webcast on the FDA and Off-Label Uses of Medical Products. Coincidentally in the wake of the 2016 presidential election, the Food and Drug Administration (FDA) is reevaluating its rules on how drug and device companies disseminate information. The change that the FDA is Read More…


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Will the Election Affect the Menu Labeling Rule Section of the ACA?

Written by Michael A. Walsh on November 10, 2016

The election is over and President-Elect Trump, the candidate who promised to repeal and replace the Patient Protection and Affordable Care Act a/k/a Obamacare (the ACA), will be sworn in on Friday, January 20, 2017. The ACA covers a number of issues that are not ordinarily associated with healthcare, including nutrition labeling of “standard” menu Read More…


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FDA’s Off-Label Hearing Set for the Day after the 2016 Election

Written by Michael A. Walsh on September 6, 2016

On September 1, 2016 the Food and Drug Administration (FDA) issued its Notice of Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (FDA’s Off-Label Hearing). The FDA’s Off-Label Hearing is scheduled for November 9-10, 2016, the Wednesday and Thursday immediately following the 2016 national election. The FDA’s Off-Label Hearing Read More…


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Mitigation Strategies Protect Food Against Intentional Adulteration

Written by Michael A. Walsh on May 27, 2016

On May 27, 2016, the Food and Drug Administration (FDA) published the seventh and final rule required under the Food Safety Modernization Act (FSMA), imposing new duties on domestic and foreign food companies to prevent intentional adulteration of food. The new rule, like all of the new FSMA rules, is preventative and thus requires implementation Read More…


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FDA is KIND about Healthy and Tasty

Written by Michael A. Walsh on May 11, 2016

As the self-appointed protector of consumers’ ability to understand product labels, the FDA has again attempted to demonstrate what Mel Brooks made famous in his movie The History of the World, it’s “good to be the king.” In a March 2015 Warning Letter, the FDA threatened KIND LLC with, among other things, an enforcement action Read More…



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