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Legalization of Products Containing CBD? Not Quite Yet, Says FDA

The Agency plays a significant role in the evolving legal landscape governing certain cannabis-derived products. Key Points: ..New law lifts or eases some, but not all, federal obstacles for certain cannabis-derived...more

FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients. On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more

FDA Issues Final Rule on Abbreviated New Drug and 505(b)(2) Applications

New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016. On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more

Amarin Settles Off-Label Promotion Case Against the FDA

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

A Look at the FDA’s New Social Media Guidance

Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age. On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing...more

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