Course Content
Introductory FDA Remarks
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Introductory FDA Remarks
00:00
Device Development and Evaluation
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Abstract
00:00
Device Development and Evaluation
00:00
Quality Considerations for Optical Imaging Drugs
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Quality Considerations for Optical Imaging Drugs
00:00
Nonclinical Safety Assessments for Optical Imaging Drugs
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Nonclinical Safety Assessments for Optical Imaging Drugs
00:00
Clinical Trial Design and Analysis: Clinical Considerations
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Clinical Trial Design and Analysis: Clinical Considerations
13:07
Novel Design and Methodology in View of Clinical Reality in Optical Imaging Drug Development
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Novel Design and Methodology in View of Clinical Reality in Optical Imaging Drug Development
17:05
Optical Surgical Navigation (OSN) Workshop: Discovery to Clinical Acceptance Part 2
Talk Summary:
Overview of regulatory pathways, precedent, and evaluation of devices intended to visualize optical imaging products.

Presenter Biography:
Dr. Colin Chen currently is a Team Leader in the Cancer Diagnostics and Treatment Devices Team, Division of General Surgery, Center for Devices and Radiological Health at FDA. Dr. Chen received his Ph.D. in biophyscs. He has been working on laser and light-based technology for more than 10 years. His current focus is the development, validation, and regulation of optical imaging devices and their use in conjunciton of drug agents as combination products.

Author

Colin Chen
Food and Drug Administration
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