FDA Utilization of Patient Preference Information in Regulatory Development & Decision Making

Patient advocacy and engagement have evolved into critical aspects of healthcare development and management in recent years, as patient and care partners seek greater involvement in treatment evaluation and decision making. The FDA recognizes and supports this through its Patient Preference Initiative, which includes the recently released guidance on “Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders”. While the FDA stresses the benefits and value of PPI, which reviewers, industry, patient groups, and other stakeholders are also encouraged to collect and analyze for additional information, they also recognize that PPI is not useful or necessary for all devices and must be utilized under the proper conditions.

  • Discussing key considerations and definitions in final guidance
  • Preference sensitive–when PPI is informative for regulatory decision making
  • Recommended qualities/characterizes of PPI included in clinical studies
  • Appropriate techniques for gathering data with practical examples
    • Data generation
    • Documentation

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Regulatory Submissions
  • Clinical Research
  • Data Management

 

 

 

 

 

 

 

 

 

Anindita (Annie) Saha
Director, External Expertise and Partnerships
Center for Devices and Radiological Health
Office of the Center Director

 

Anindita (Annie) Saha is the Director of External Expertise and Partnerships (EEP) in the FDA’s Center for Devices and Radiological Health (CDRH). Ms. Saha leads CDRH’s Patient Preference Initiative to incorporate patient perspectives on benefits and risk in regulatory decision-making. She is also helps coordinate CDRH’s larger Strategic Priority to Partner with Patients to incorporate patient engagement and the science of patient input in device design, assessment, and review. EEP also develops and manages CDRH’s external collaborations and partnerships including the Network of Experts program, public-private partnerships including the Medical Device Innovation Consortium (MDIC), fellowship programs including the Medical Device Fellowship and AIMBE Scholars programs, and technology transfer and collaboration efforts for the Center. EEP directs and coordinates CDRH’s Regulatory Science and Critical Path programs to facilitate research to promote the development and assessment of high quality, safe, and effective medical devices. Ms. Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies before moving to EEP to coordinate Critical Path and Regulatory Science activities for the Center. Ms. Saha has a Bachelor of Science in Bioengineering and Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.

 

 

 

 

 

 

 

Martin Ho
Associate Director for Quantitative Innovation
Center for Devices and Radiological Health
Office of Surveillance and Biometrics

Martin Ho, MS, is the Associate Director for Quantitative Innovation at the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health (CDRH) of the FDA. He leads the Quantitative Innovation Program (QuIP) which provides methodological leadership to incorporate novel quantitative methods into regulatory decision making. QuIP works with review teams across CDRH to conduct reviews of submissions with innovative methods, develops good review practices for these methods (such as evaluating patient preferences and patient-reported outcome), and builds review capacity to meet CDRH’s long term needs. QuIP also provides technical expertise to the patient-related regulatory science projects funded by CDRH. Mr. Ho participated in developing the FDA’s Patient Preferences Information Guidance released in 2016. He is the Past President of the FDA Statistical Association and he serves on the Medical Device Innovation Consortium’s Patient-Centered Benefit-Risk Assessment Project Steering Committee. Mr. Ho is also a voting member of the FDA Research Involved Human Subject Committee, which reviews IRB applications of all the clinical studies funded by the FDA. Mr. Ho was a statistical reviewer, team leader, and acting branch chief reviewing medical device submissions of various therapeutic areas before QuIP was created. Prior to joining the FDA in 2009, Mr. Ho was a senior statistician in various contract research organizations planning and conducting clinical studies for 10 years.


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