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    Companies Collaborate on DSCSA Guideline as Deadlines Approach

    Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013. In preparation for that deadline and others over the next seven years, a diverse group of 44 companies – from manufacturers to wholesalers to solution providers – came together to develo...
  • Anvisa Approves Track and Trace System

    The board of Brazil's National Health Surveillance Agency, Anvisa, has approved a system that will be used to track drugs from manufacture to the time of sale. Within three years, drug packaging will have a two-dimensional code, and the industry will need to have in place an electronic system to monitor each step of the package, from the factory to the pharmacy. In the case of prescription drugs, the monitoring will go further, with the ability to know who purchased a...
  • PhRMA, GPhA Call for Revival of Pharmaceutical Track and Trace Measures

    The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) was remarkable for both the number of reform provisions contained within it and the overwhelming support it received in the US Congress. But that support was not earned without some hard negotiating, and several prominent but controversial provisions were dropped from the final iterations of the bill. Now some of the industry's most prominent voices are taking to the Washington press...
  • Medical Device Group Calls for More Transparency on Proposed Naming Conventions

    A medical device-focused scientific advocacy group is calling on the US Food and Drug Administration (FDA) to make changes to a recently proposed regulation set to make big changes to the way medical devices are tracked after being introduced to the market. In a statement on 11 October, the Emergency Care Research (ECRI) Institute said it is "concerned" about FDA's Unique Device Identification (UDI), set to come into effect within the next year. The rule -long delayed...
  • Extension Proposed for Comment Period on Important Medical Device Rule

    The US Food and Drug Administration (FDA) is proposing to extend the comment period on a proposed rule that would overhaul the way medical devices are overseen by regulators, it has announced. In July 2012, FDA released a long-awaited rule on a Unique Device Identification (UDI) system which would require most medical devices to carry an identification number and/or barcode capable of tracing the device back to its point of origin. Though the rule was mandated under l...
  • Report: Human Tissue Donation Rules Lack 'Inadequate Safeguards'

    • 18 July 2012
    An investigation into human tissue trafficking by The International Consortium of Investigative Journalists (ICIJ) has uncovered "inadequate safeguards" to protect consumers from poorly-sourced human tissue products. "Despite concerns by doctors that the lightly regulated trade could allow diseased tissues to infect transplant recipients with hepatitis, HIV and other pathogens, authorities have done little to deal with the risks," ICIJ wrote. "In contrast to tightly-mon...
  • FDA Unveils Proposed Device Identification System, New Database

    The US Food and Drug Administration (FDA) announced Tuesday, 3 July its intent to implement a long-delayed Unique Device Identifier (UDI) rule, which would mandate most medical devices carry an identifier capable of allowing the device to be traced back to its point of origin. The UDI rule was mandated by the FDA Amendments Act (FDAAA) of 2007, but the rule has thus far failed to be implemented due to a confluence of factors including industry criticism and a stalled r...
  • With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy

    • 03 May 2012
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced it has signed on to a Memorandum of Understanding (MoU) that it says will help to set up a harmonized system of international standards to prevent counterfeit products from entering or proliferating within the pharmaceutical supply chain. EFPIA said the MoU, reportedly developed jointly between groups representing pharmacists, wholesalers and distributors, adopts what is known at the ...
  • EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy

    • 18 April 2012
    The European Directorate for Quality in Medicines and Healthcare ( EDQM ), the Council of Europe's (EC) pharmaceutical standards body, announced it is continuing to develop and expand a new anti-counterfeiting strategy it says will reduce pharmaceutical-related crime. In its 18 April announcement, EDQM said the multi-layer legislative strategy aims to increase, among other things, training for inspection officials from EC member states, increased inspection and testing a...