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Another One Bites the Dust: FDA doesn’t like the fishy smell of the latest court decision on off-label dissemination

USA - August 19 2015 The Food and Drug Administration has lost yet another court decision challenging its ability to restrict a company's commercial free speech rights...

William H. Kitchens.


The OIG applauds FDA’s progress in inspections of generic drug manufacturers but recommends more to be done

USA - July 23 2015 The Department of Health and Human Services' Office of Inspector General has recently recommended that the Food and Drug Administration continue to...

Alexander B. Foster.


States seek to expand access to investigational drugs, biological products, and devices through “Right to Try” laws

USA - June 24 2015 Since early 2014, at least forty states have introduced "Right to Try" laws, and twenty-two of those states have passed "Right to Try" laws. The goal...

W. Jerad Rissler.


Off-label promotion, state-level injury lawsuits, and preemption

USA - June 23 2015 The issue of preemption in product liability cases involving medical device products continues to evolve. Recently, the U.S. Court of Appeals for the...


FDA issues ban on artificial trans fat in processed foods

USA - June 23 2015 On June 15, 2015, the U.S. Food and Drug Administration announced a final determination order regarding the use of partially hydrogenated oils (PHOs)...

William H. Kitchens.