FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S050 · decided 2023-12-01
Approval details
- PMA number
- P170019
- Supplement
- S050
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- FoundationOne CDx (F1CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2023-11-03
- Decision date
- 2023-12-01
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval of the clinical protocol entitled FoundationOne®CDx Clinical Validation Protocol RET Fusions Clinical Efficacy Post-Approval Study for Selpercatinib
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