FDA Pushes New Regulatory Science Initiative

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Michael Causey
In FDA Regulated Industries

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

A new FDA report suggests the agency is trying to get some of its regulatory swagger back after budget cuts and brain drains hampered much of its work in the George W. Bush years.

At the core of yesterday’s (Oct. 6, 2010) FDA announcement by Commissioner Margaret A. Hamburg M.D., the agency proposes to build on what it calls the success of the Critical Path Initiative and other projects by leading an effort to advance regulatory science through its new Regulatory Science Initiative. Hamburg spoke today at the National Press Club in Washington, D.C.

The FDA initiative will be supported by a four-part framework:

  • Leadership, coordination, strategic planning and transparency to support science and innovation
  • Support for mission-critical applied research, both at FDA and collaboratively
  • Support for scientific excellence, professional development and a learning organization
  • Recruitment and retention of outstanding scientists

FDA plans to use its requested $25 million budget to expand ongoing efforts within the agency and build additional partnerships with academia, industry and government around the country. A new office dedicated to regulatory science will lead strategic development and coordination within FDA, and early efforts will focus on recruiting key personnel and building senior leadership, Hamburg said.

In FY2011, the bulk of the budget will be used to mobilize external collaborations and partnerships and support studies in four major regulatory science research areas:

  1. Transforming Product Development for Patients: Bringing Progress to Patient (eg: Methods for Modernizing Toxicology, Biomarkers for Personalized Medicine, the Stem Cell Initiative and Updating Drug Review Standards)
  2. Science to Address Emerging Technologies in FDA-regulated Products (eg: Nanotechnology and Expertise to Regulate New Animal Biotech Products)
  3. Information Sciences for Health Outcomes (eg: Medical Device Registry and Scientific Computing for Data Analyses)
  4. Addressing Unmet Public Health Needs (eg: Nutrition and Public Health)

Activities in FY2011 will also set the stage for a network of Centers of Excellence in Regulatory Science to be integrated with expanded intramural FDA research and with other clinical research networks, Hamburg added. Funding for external programs would be competitive and focus on pilot and feasibility studies to form Centers of Excellence

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