STAT+: FDA weighs animal data, ethical dilemmas at panel on artificial wombs

An FDA panel, assessing the artificial womb technology, grappled with the limits of current animal data, as well as the ethical difficulties in running human trials.

Sep 20, 2023 - 20:00
STAT+: FDA weighs animal data, ethical dilemmas at panel on artificial wombs

The Food and Drug Administration’s advisory panel of pediatric experts met on Tuesday to discuss advances in artificial womb technology, which aim to save the lives of premature babies.

The goal of the meeting was to discuss measures for evaluating the safety and efficacy of an artificial womb. The group grappled with the limits of current animal data, as well as the ethical difficulties in running human trials. On Wednesday, the committee’s meeting will be closed to the public in order to protect trade secrets.

Extremely premature babies, defined as infants born at less than 28 weeks, rarely survive. About half of infants born at 23 weeks survive, according to a 2022 study in the Journal of the American Medical Association, and at 22 weeks just 10% survive. This population represents less than 2% of all premature babies, but the problem is growing; the Centers for Disease Control and Prevention reported that the preterm birth rate rose by 4% between 2020 and 2021.

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