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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…

David L. Rosen

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USA - August 28 2015 On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products.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

David L. Rosen, 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…

Michael D. (Mike) Flanagan, Christopher J. Hanson, David L. Rosen

Medical device industry responds to FDA’s overseas clinical trial proposed rule

USA - June 16 2013 In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration's proposed rule…

Jennifer M. Forde, David L. Rosen

FDA’s plan to regulate LDTs

USA - June 13 2013 In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests…

Jennifer M. Forde, David L. Rosen