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  • Regulatory NewsRegulatory News

    Importers of FDA-Regulated Products Prepare for February Shift to Automated System

    In partnership with Customs and Border Protection (CBP) and 46 other government agencies, the Food and Drug Administration (FDA) has developed and is quickly transitioning to a new portal through which industry can electronically submit all data required by government agencies for international trade. As of 28 February, 2016, all importers and brokers of FDA-regulated products will have to submit entry data through the new Automated Commercial Environment (ACE). And by t...
  • 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 ...
  • Report Finds that Pharmaceutical Counterfeiting Busts Fell in 2012

    An annual report just issued by the US Customs and Border Patrol (CBP) shows that counterfeit and pirated goods experienced "explosive growth" in 2012, causing problems for healthcare product regulators who continue to struggle with ways to prevent counterfeit products from entering the supply chain. The Scale of the Problem: Big, but less so for Pharmaceuticals Purveyors of counterfeiters often use a tried-and-true tactic to get counterfeit products into the country:...
  • CBP Report Shows Dramatic Increase in Counterfeit Pharmaceutical Seizures

    • 11 January 2012
    A new report released by the US Customs and Border Protection (CBP) on 9 January shows a dramatic increase in the amount of counterfeit pharmaceutical products seized by CBP during fiscal year (FY) 2011. Pharmaceutical products represented the third most popular category of commodities seized by CBP during FY 2011, representing 1,239 seizures worth $16.9 million, or 9% of all the value of all goods seized. This represents a three-fold increase over 2010, when CBP seize...
  • Import Regulations Used as Delaying Tactic in Nebraska Execution Case

    The state of Nebraska was the epicenter of a convergence between US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) import regulations and death penalty politics on 9 January. Attorneys for death row inmate Michael Ryan had sued the state of Nebraska to produce documents proving that the state had legally obtained the execution drug sodium thiopental. Nebraska Attorney General Jon Bruning produced documents Monday showing that Nebraska had ...