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  • Feature ArticlesFeature Articles

    Strategies for managing regulatory risk with third-party distributors

    In today’s global healthcare distribution market, an increasing number of medical device and in vitro diagnostic medical device (IVD) companies are aspiring to market globally. One of the main challenges these manufacturers face is how to register and distribute their products internationally. While direct distribution channels may be feasible for larger multinational corporations, third-party distribution brings its own advantages, and is becoming the norm in today’s land...
  • Regulatory NewsRegulatory News

    FDA delays enforcement of some DSCSA provisions by three years

    The US Food and Drug Administration (FDA) last week announced it will again delay enforcement of a provision of the Drug Supply Chain Security Act (DSCSA) that would require wholesalers to verify saleable returned drugs they intend to further distribute.   “FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under section 582(...
  • After Counterfeit Avastin Infiltrates Supply Chain, FDA Goes After Doctors

    The US Food and Drug Administration (FDA) is going after doctors in an attempt to protect the pharmaceutical supply chain from more instances of counterfeit medicines, reports Medscape News . There have been two instances of fake Avastin being found in the US in 2012-one in early April and another in mid-February . Both cases involved doctors deviating from approved suppliers to purchase Avastin from unauthorized wholesalers. While FDA Commissioner Margaret Hamburg ...