• Regulatory NewsRegulatory News

    EMA Finds No Difference in Inhibitor Risk Between Factor VIII Classes

    The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor VIII medicines. The announcement reconfirms EMA's conclusion from two earlier reviews of factor VIII medicines in 2013 and 2016 . The development of inhibitor antibodies is one of the greatest potential complications involved with treating patients with hemophilia A. When...
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    Final FDA Rule Reworks Import Data Submissions

    The US Food and Drug Administration (FDA) on Tuesday issued a final rule requiring companies to submit data for FDA-regulated products via a new electronic system intended to serve as a "single access point" for imported products. Specifically, the final rule, which takes effect on 29 December 2016, will require companies to submit the data through the Automated Commercial Environment (ACE), which was developed in collaboration with US Customs and Border Protection (CBP...
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    FDA Pilot Project to Test New Import Communication System

    The Food and Drug Administration (FDA) on Wednesday said it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) and is seeking participants. The purpose of the pilot is to test and evaluate a new ITACS account management function with user login accounts that enable FDA to distribute “Notices of FDA Action” to users electronically via email (rather than regular mail) and enable users to download such notices....
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    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...
  • Group Calls for REMS-Like Conditions for Popular Hypertension Drugs

    The public safety advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to place additional safety warnings and restrictions on several classes of hypertension drugs due to safety concerns. In a petition sent to FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock on 4 October, Public Citizen said three types of hypertension drugs-angiotensin-converting enzyme (ACE) inhibitors, angiotensin...