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  • Regulatory NewsRegulatory News

    FDA Launches New 'Trusted Trader' Import Program With Long List of Incentives

    The US Customs and Border Protection (CBP) and US Food and Drug Administration (FDA) have announced the launch of a new "Trusted Trader" program meant to expedite the import of products made by companies that meet a rigorous selection process. Background FDA and CBP have long sought to make improvements to the process used to import of products, and particularly pharmaceuticals. As explained in numerous Federal Register announcements over the years, the problem ...
  • Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto

    The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer's co-developed oral anticoagulant drug Xarelto (rivaroxaban), which the companies were looking to market as a therapy for Acute Coronary Syndrome (ACS). Xarelto is already FDA-approved for reducing the risk of blood clots in limited populations. The advisory committee had expressed some doubts regarding the drug on 22 May, saying m...