Life Sciences Regulation And Legislation To Watch In 2014

Law360, New York (January 1, 2014, 10:08 AM EST) -- Recent directives by the U.S. Food and Drug Administration, federal courts and Congress will drive some big regulatory shifts in the life sciences field in 2014, with attorneys watching especially the implementation of the newly passed Drug Quality and Security Act and the regulation of direct-to-consumer marketing.

Life sciences attorneys are also eagerly expecting the biosimilars guidance the FDA promised in October, which could pave the way for the first-ever biosimilar product approval since legislation on the novel treatments was approved five years ago. Pharmaceutical firms are also awaiting the FDA's reaction to a major Second Circuit ruling in late 2012...

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