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The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more
New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016. On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more