Regulatory Science Playbook

Accelerating medical tech to advance public health

An ever-expanding landscape of new medical products and therapies demands an equally fast-moving evolution of regulatory actions and policy. From brand new drugs to insulin delivery devices and cancer screening equipment, agencies including the Food & Drug Administration and the Center for Drug Evaluation & Research face the challenges of rapidly evolving science and technology.

And these new therapies and medical products are increasingly complex in their development, manufacture, and regulation. New laws and national standards that reduce risks and improve transparency can sometimes slow the process. We’re working to keep that process smooth.

Regulatory science is what we call the study of developing and enhancing tools, techniques, and policy that informs regulatory actions, ultimately to promote public health. Read about our approach, our case studies, and our dedication to advancing medicine in the Regulatory Science Playbook.

As Milestone 8 mandates hit, inspections begin. Starting in mid-2017 and extending into 2020, the NRC will inspect each of the nation’s nuclear plants for Milestone 8 compliance, focusing on seven areas in particular:

  • Detection, response, and elimination
  • Defense-in-depth
  • Supply chain
  • Data integrity
  • Asset monitoring, assessment, configuration, and change management
  • Attack migration, incident response, and contingency planning
  • Personnel training, education, communications, and certifications

Completing Milestone 8 is a significant achievement. Utilities across the country have invested substantial time and resources toward developing, implementing, and sustaining advanced cybersecurity programs that meet the NRC’s necessarily exacting standards.

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