Partnerships

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The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

  The provisions in the Trans-Pacific Partnership (TPP) dealing with patent exclusivity periods are diametrically opposed to the main goals originally outlined in the Biologics Price Competition and Innovation Act of 2009 in the Patient Care Protection and Affordable Care Act, the Biosimilars Council wrote in an open letter to President Obama on July 27, 2015.