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Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

USA - July 5 2016 Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced…

Jason L. Drori, Katy E. Koski, James W. Matthews

FDA Panel Shows Strong Support for a Remicade Biosimilar

USA - February 11 2016 The Food and Drug Administration's (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson's Remicade product…

Nathan A. Beaver

“Better, faster, stronger” — identifying and protecting your competitive differentiators

USA - November 17 2015 Competitive differentiators are the beneficial and unique aspects of your product or service compared to those of competitors. These qualities may…

Christopher J. McKenna

FDA’s proposed naming convention for biologics

USA - August 28 2015 On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency's…

Nathan A. Beaver, Anna S. Ross

FDA takes steps to declare partially hydrogenated oils no longer gras and seeks comments

USA - November 7 2013 On November 7, 2013, the Food and Drug Administration (FDA) announced that it has tentatively determined that partially hydrogenated oils (PHOs) are…

Nathan A. Beaver, Michael D. (Mike) Flanagan, Christopher J. Hanson