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doi: 10.1016/s0140-6736(17)30703-1 76 DelitalaAP

Sanin, D

10.1001/jamanetworkopen.2024.10056 26

The 510(k) process includes a comprehensive review of the safety and performance data for the device, potentially including scientific, non-clinical, and clinical data

Sex hormones and associated immune regulation strongly influence disease progression, and omitting female subjects may obscure sex-dependent pathogenic mechanisms and therapeutic responses