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FDA schedules meeting to establish regulatory rules for artificial womb trials (fda.gov)
57 points 98 comments
57 points 98 comments
FDA approves first gene therapy treatment of Duchenne muscular dystrophy (fda.gov)
239 points 73 comments
239 points 73 comments
FDA Draft Guidance: Change Control Plans for AI/ML-Enabled Medical Devices (fda.gov)
1 point 1 comment
1 point 1 comment