FoundationOne CDx
FDA premarket approval P170019/S037 · decided 2023-05-26
Approval details
- PMA number
- P170019
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- FoundationOne CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2022-08-12
- Decision date
- 2023-05-26
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval of the clinical protocol entitled Statistical Analysis Plan for Real-World Evidence Study Supporting FoundationOne®CDx as a Companion Diagnostic for Entrectinib in Non-Small Cell Lung Cancer Patients with ROS1 Fusions
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