FDA Guidances: Antimicrobial Drug/Device Coordination, Computational Modeling, Total Kidney Volume
FDA BRIEF: Week of September 19, 2016
SCOPE : For coordinated development of new antimicrobial drug and an antimicrobial susceptibility test (AST) device to streamline CDER and CDRH reviews and approvals
- Interactions between drug sponsors and device manufacturers
- Considerations for submitting separate applications to CDER and CDRH
- Clarify independent review of drug product and device
- Maximize likelihood of coinciding device and drug approvals
CONSIDERATIONS FOR COORDINATED DEVELOPMENT
- Submit coordinated development plans to CDER and CDRH, respectively, for review and comment
- Joint meetings with drug sponsor and device manufacturer and personnel from both CDER and CDRH
- Use CDRH pre- submission process
- CDRH communicate with CDER and review the 510(k) submission during the NDA review process
SCOPE
- Computational Modeling and Simulation (CM&S) studies to support device design/development and CDRH submissions
- Provide recommendations formatting, organization, and content of CM&S reports
- Improve consistency and predictability of FDA review
TRADITIONAL USE
- Fluid dynamics
- Solid mechanics
- Electromagnetics and optics
- Ultrasound propagation
- Thermal propagation
CM&S REPORT OUTLINE
- Executive Report Summary
- Background/Introduction
- Code Verification
- System Configuration
- Governing Equations/Constitutive Laws
- System Properties
- System Conditions
- System Discretization
- Numerical Implementation
- Validation
- Results
- Discussion
- Limitations
- Conclusions
PURPOSE
- TKV: Sum of the volume of the left and right kidneys
- Qualified context of use (COU) for TKV in studies for the treatment of autosomal dominant polycystic kidney disease (ADPKD)
CONTEXT OF USE
- Use Statement: Prognostic enrichment biomarker, TKV-based patient selection