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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 ...
  • FDA Calls for Comments on Adverse Event Reporting for Medical Devices

    The US Food and Drug Administration (FDA) is calling for medical device manufacturers, importers and facility owners to provide feedback on how FDA collects information related to reports of serious adverse events-or potential events-related to medical devices. The collection of this information is currently mandated under §519(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , which says that "whenever the manufacturer or importer receives or othe...