Blood Supply and Demand Simulation Model Could Help Nation Prepare for Emergencies

FDA developed blood supply model to estimate amount of blood available in system during national emergencies

  • Estimates how much blood is available during pandemic influenza outbreak and  mass casualty event caused by nuclear device detonation
  • Could threaten blood supply by reducing number of people to donate or by increasing the amount of blood needed
  • Allows calculation of supply—and potential for shortages—based on how long RBCs (short half life) have been in storage

Based on real-world sources of data

  • National blood supply produced by America’s Blood Centers
  • Center for Medicare and Medicaid Center for Medicare and Medicaid Services database
  • National Blood Collection and Utilization Survey
  • Centers for Disease Control and Prevention

Ran simulation on how pandemic could affect inter-regional blood supplies

  • Estimated 541,000 RBC units were lost overall; South had highest percentage of blood lost (15.5%), while the East had the lowest lost (13.8%)

Based on current levels of blood collection, use, and other factors, the U.S. blood supply and demand system is flexible and reliable enough to respond to emergencies

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Nanotechnology Programs at FDA

Build regulatory science knowledge, facilitate collaborations and partnerships to establish a flexible, product-focused, science-based approach to regulation

  • Nanotechnology Task Force
  • Nanotechnology Task Force Report
  • Nanotechnology Guidance Documents
  • Nanotechnology Partnerships at FDA

National and International Activities 

  • Member agency in the National Nanotechnology Initiative
  • World-class R&D program, transfer of new technologies,  educational resources,  infrastructure and tools to advance and responsible development of nanotechnology
  • International Organization for Standardization (ISO)
  • Organisation for Economic Co-operation and Development (OECD)

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FDA’s efforts to enhance the patient perspective and experience in drug development and review

Patients are becoming driving force of medical research enterprise

  • Capturing patient experience may be quantitative or qualitative
  • Transforming nearly every aspect of medical product development
  • Informing about benefits that matter most and risks they are most concerned

Benefit-Risk Assessment in Drug Regulatory Decision-Making

  • Enhance benefit-risk assessment in human drug review and FDA’s decision-making process
  • Outline how patient experience data and related information can be used to inform benefit-risk assessment

Incorporating Patient Voice into Benefit-Risk Assessments

  • Inform clinical context and provide insights to frame assessment of benefits and risk
  • Provide a direct source of evidence regarding the benefits and risks based on  methodologically-sound data collection tools
  • Hosting patient-focused drug development public meetings
  • Encouraging patient stakeholders to conduct externally-led, patient-focused drug development meetings
  • Providing patients, caregivers, advocates  more channels to provide meaningful input
  • Launching pilot programs to foster design of clinical trials that place less burden on patients

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Image credits: FDA

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