BOX 5-1FDA Resource and Infrastructure Observations

Although both the National Biodefense Science Board (NBSB) and the IOM have previously issued strong recommendations for increased resources for FDA, in the current fiscal climate the significant increases that are needed are not likely to occur.

Resources are specifically needed to support the following regulatory science-related activities:

  • The process of evaluating an increasing number of new technologies, and research to resolve new regulatory science challenges.
  • Leadership development (scientific and professional) to strengthen science within the agency.
  • Recruitment and retention of scientific talent and technical expertise.
  • Establishing collaborations and partnerships.
  • Academic Centers of Excellence in regulatory science to promote a better understanding of the development of MCMs and provide training.
  • Information sciences.
  • Biostatistics.
  • Genomics.
  • Synthetic biology.

SOURCE: Cassell presentation.

From: 5, Crosscutting Themes and Future Directions

Cover of Advancing Regulatory Science for Medical Countermeasure Development
Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary.
Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation; Institute of Medicine (US) Forum on Medical and Public Health Preparedness for Catastrophic Events.
Washington (DC): National Academies Press (US); 2011.
Copyright © 2011, National Academy of Sciences.

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