Comment from Heartbeat International, Inc.

Summary: Heartbeat International, Inc., a nonprofit organization providing pregnancy resources, opposes GenBioPro, Inc.'s petition to maintain relaxed regulations on mifepristone. They argue that the FDA should instead strengthen the Risk Evaluation and Mitigation Strategy (REMS) by reinstating in-person dispensing, mandatory adverse event reporting, and ultrasound requirements to ensure patient safety and informed consent.