Rosen Quoted on Gilead Sciences' Lost Bid for NCE Exclusivity

18 April 2014 FDA Week News

FDA Week

Partner David Rosen was quoted in an article published in FDA Week on April 18, 2014, titled “FDA Argument For 5-Year NCE Exclusivity Denial Unfounded, Gilead Says.” The article explains the appeal by Gilead Sciences, a manufacturer of one of three drug-drug combination products, asking the Federal Drug Administration (FDA) to reconsider its decision to prospectively change its new chemical entities policies for other combination drugs. Rosen was quoted saying, “One thing you can appreciate is FDA is very considered in its decision-making process at this time.”

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