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  • Regulatory NewsRegulatory News

    FDA's Long, Long Search for a Chief Information Officer

    The US Food and Drug Administration (FDA) is having a difficult time finding a suitable candidate for its vacant chief information officer (CIO) position. Background FDA has been without a permanent CIO since March 2013, when Eric Perakslis, formerly of Johnson & Johnson, left the agency after just six months . The position has been filled on an acting basis since then by Walter Harris , who is also FDA's deputy commissioner for operations. As FierceBiotechIT note...
  • FDA Looks to Hire New CIO, CFSAN Compliance Director

    The US Food and Drug Administration (FDA) has announced it is searching for a new chief information officer (CIO) to run technology operations at the agency, as well as a permanent director of its Office of Compliance (OC) for its Center for Food Safety and Applied Nutrition (CFSAN). CIO Position FDA has gone through several CIOs in recent years as it has struggled to upgrade its technology platforms in light of an increasingly global workforce, hacking attempts , new ...
  • BIO Head Calls for New Position to be Formed at FDA to Boost Innovation

    The head of the Biotechnology Industry Organization (BIO), the leading trade group for biotechnology and biopharmaceutical organizations in the US, called on the US Food and Drug Administration (FDA) to make room in its organizational structure for a Chief Innovation Office (CIO), reports The Boston Business Journal . Speaking at the organization's annual meeting in Boston, BIO President and CEO James Greenwood said FDA has a duty to go beyond its mission to protect con...
  • Report: Future of FDA's $280 Million IT Improvement Program 'Uncertain'

    A report issued by the Government Accountability Office (GAO) has found the US Food and Drug Administration's (FDA) information technology (IT) infrastructure improvement project-a $280 million program known as the Mission Accomplishments and Regulatory Compliance Services (MARCS) program-is suffering from a cavalcade of operational deficiencies and may not be completed. The program "is intended to enhance existing applications and develop new systems that provide infor...