NIH - FDA Meeting

Agenda

10:00 - 10:20 a.m. Introductory Remarks
Nora D. Volkow. MD, Director, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Suzanne Schwartz, MD, MBA, Director, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA)
 
10:20 - 10:35 a.m. Research and Device Development Considerations for Monitoring Devices
Stacie Gutowski, PhD, NIDA
 
10:35 - 10:50 a.m. Regulation of Medical Devices for Opioid Use
Marianela Perez-Torres, PhD, FDA
 
10:50 - 11:00 a.m. Patient Science and Engagement Program and Medical Device Development
Eva Rorer, MD, FDA
 
11:00 a.m. - 12:30 p.m. Patient Panel: Health Effects and Daily Impacts of Opioid Use on Patients
Co-moderators:
Kathryn Capanna, CDRH, FDA
Gioia Guerrieri, DO, CDER, FDA
  • Patient Panel Discussion
12:30 - 1:15 p.m. Lunch
 
1:15 - 2:05 p.m. Medical Devices for Opioid Use: Challenges and Opportunities
Session Planning Leads/Presentation Chair
Moderators:

Charles Viviano, MD, PhD, FDA
Leonardo Angelone, PhD, NIDA
  • Opportunities for Monitoring and Prevention Across the Spectrum of Opioid Use
  • Clinical Outcome Assessments (COA), Biomarkers, and other Tools to Evaluate Device Performance
  • Innovative Digital Health Technologies across the Spectrum of Opioid Use
  • Considerations for Care in Adolescent Patients Using Opioids
  • Questions and Answers
2:05 - 2:15 p.m. Break
 
2:15 - 3:10 p.m. Multistakeholder Panel Discussion: Scenario #1 - Preventing and Detection of Overdose in the Outpatient Setting
Moderators:
Vivek Pinto, PhD, FDA
Leonardo Angelone, PhD, NIDA
3:10 - 3:20 p.m. Break
 
3:20 - 4:15 p.m. Multistakeholder Panel Discussion: Scenario #2 - Facilitating Remote Monitoring for Stress and Cravings
Moderators:

Anindita (Annie) Saha, FDA
Stacie Gutowski, PhD, NIDA
4:15 - 4:30 p.m. Closing Remarks and Day Summary
Michelle Tarver, MD, Deputy Director, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA)
Leonardo Angelone, PhD, Deputy Director, Office of Translational Initiatives and Program Innovations (OTIPI), National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
 
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