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FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

USA - December 21 2017 On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft guidance stating that the Agency no longer intends to grant...

Chad M. Jennings, John R. Manthei, Carolyne R. Hathaway.


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

USA - October 6 2016 On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule (the Final Rule) in the Federal Register...

Morgan A. Rettig, J. Benneville (Ben) Haas, John R. Manthei.


Amarin Settles Off-Label Promotion Case Against the FDA

USA - March 14 2016 On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in the off-label promotion case, Amarin...

Morgan A. Rettig, Adam M. Susser, John R. Manthei, Daniel Meron.


A look at the FDA's new social media guidance

USA - February 13 2014 On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing industry with long-awaited insight into how...

Carolyne R. Hathaway.