Tag Archives: FDA Law Blog

FDA’s New Biosimilars Guidance

The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog. *** August 09, 2014 FDA’s New Biosimilars Guidance Has Sponsors … Continue reading

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“We Don’t Need No Stinkin’ Patents” – Antibiotic and Antifungal Drugs Gain Non-Patent Exclusivity

Posted on the FDA Law Blog by Kurt Karst on June 19, 2014. After years of relative quiet, the Orange Book list of exclusivity terms has gotten quite a workout over the past year with the addition of several new terms … Continue reading

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