Morgan Lewis on Life Sciences
January/February 2005

In this Issue:

• Outsourcing in the Pharmaceutical Industry:
  Most if not all major pharmaceutical companies have outsourced, or are evaluating the benefits of outsourcing, one or more of their non-core business functions to a third-party service provider.
• Legal and Regulatory Implications of FDA's Modernization of Pharmaceutical cGMPs:
  On September 29, 2004, the Food and Drug Administration (FDA) issued its final report on the Agency’s two-year initiative to enhance and modernize pharmaceutical current Good Manufacturing Practice (cGMP) requirements. This initiative, termed “Pharmaceutical cGMPs for the 21st Century,” was launched in 2002 to modernize the regulatory scheme for pharmaceutical cGMPs, which has not been significantly revised since its inception in 1978.

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